Suspended

Vaccine Therapy and Sargramostim With or Without Docetaxel in Treating Patients With Metastatic Lung Cancer or Metastatic Colorectal Cancer

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What is being tested

recombinant fowlpox-CEA(6D)/TRICOM vaccine

+ recombinant vaccinia-CEA(6D)-TRICOM vaccine
+ docetaxel
Drug
Who is being recruted

Extensive Stage Small Cell Lung Cancer
+5

+ Recurrent Colon Cancer
+ Recurrent Non-small Cell Lung Cancer
Over 18 Years
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: June 2004

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: March 31, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2004Actual date on which the first participant was enrolled.

This randomized phase I trial studies the side effects, best way to give, and best dose of docetaxel when given together with vaccine therapy and sargramostim in treating patients with metastatic lung cancer or metastatic colorectal cancer. Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow and peripheral blood. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy and sargramostim with docetaxel may kill more tumor cells. OBJECTIVES: I. Determine the recommended dose and schedule of docetaxel when given in combination with recombinant vaccinia-CEA-TRICOM vaccine, recombinant fowlpox-CEA-TRICOM vaccine, and sargramostim (GM-CSF), defined by best immune response with acceptable toxicity, in patients with carcinoembryonic antigen (CEA)-expressing metastatic lung or colorectal cancer. II. Compare the effect of varying doses and schedules of docetaxel on CEA-specific T-cell immune responses by ELISPOT assay in patients treated with these regimens. III. Compare objective antitumor response in patients treated with these regimens. OUTLINE: This is a 2-part, randomized, pilot study. Patients are randomized to 1 of 6 treatment arms: arms I, II, and III in part I (lung cancer and colorectal cancer patients) and arms IV, V, and VI in part II (lung cancer patients only). Patients are stratified according to disease site and HLA-A2 positivity (positive vs negative). At least 6 of 10 patients must be HLA-A2 positive for each of the treatment arms. Vaccinia-CEA-TRICOM vaccine (parts I and II): In all treatment arms, patients receive vaccinia-CEA-TRICOM vaccine intradermally on day 1 and sargramostim (GM-CSF) subcutaneously (SC) into the vaccine site on days 1-4. Fowlpox-CEA-TRICOM vaccine and concurrent chemotherapy: Part I (lung cancer and colorectal cancer patients): ARM 1: Three weeks after treatment with vaccinia-CEA-TRICOM vaccine, patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC into each vaccination site on days 1-4. ARM II: Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and lower-dose docetaxel IV over 30 minutes on days 1 and 8. ARM III: Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and standard-dose docetaxel IV over 30 minutes on days 1 and 8. Part II (lung cancer patients only): ARM IV: Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and full-dose docetaxel IV over 1 hour on day 1. ARM V: Patients receive full-dose docetaxel IV over 1 hour on day 1, fowlpox-CEA-TRICOM vaccine SC on day 8, and GM-CSF SC into each vaccination site on days 8-11. ARM VI: Patients receive full-dose docetaxel as in arm V, fowlpox-CEA-TRICOM vaccine SC on day 15, and GM-CSF SC into each vaccination site on days 15-18. Treatment in all arms repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Patients who do not have significant disease progression or unacceptable toxicity after 4 courses of treatment may receive additional fowlpox-CEA-TRICOM vaccine and docetaxel according to the treatment arm on which they were enrolled at study entry. Patients are followed every 6 months for 2 years and then annually for 13 years.

Official TitleRandomized Single Institution Pilot Study of Vaccinia-CEA(6D)-TRICOM and Fowlpox-CEA(6D)-TRICOM With GM-CSF in Combination With Docetaxel in Patients With CEA-Bearing Cancers 
Principal SponsorNational Cancer Institute (NCI)
Last updated: March 31, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
60 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Extensive Stage Small Cell Lung Cancer
Recurrent Colon Cancer
Recurrent Non-small Cell Lung Cancer
Recurrent Rectal Cancer
Recurrent Small Cell Lung Cancer
Stage IV Colon Cancer
Stage IV Non-small Cell Lung Cancer
Stage IV Rectal Cancer
Criteria

Inclusion Criteria: * Histologically confirmed lung OR colorectal cancer * Incurable metastatic disease * Currently available standard treatment not likely to offer a survival advantage or result in superior palliation * Evaluable disease by radiograph * Tumor must currently express carcinoembryonic antigen (CEA) by immunohistochemistry OR CEA \>= 10 ng/mL at any point during disease course * No clinically active brain metastases * Must have had first- and second-line treatment OR declined second-line treatment (part I only) * Patients with colon cancer must have had or have been offered treatment with oxaliplatin (part I only) * ECOG 0-1 * Life expectancy of at least 4 months * Absolute neutrophil count \>= 1,500/mm\^3 * WBC \>= 3,000/mm\^3 * Platelet count \>= 100,000/mm\^3 * Bilirubin normal * Meets 1 of the following criteria: * SGOT and SGPT =\< 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal * SGOT and SGPT =\< normal AND alkaline phosphatase =\<4.0 times ULN * Hepatitis B and C negative by clinical history and physical exam * Creatinine =\< 1.5 mg/dL OR creatinine clearance \>= 60 mL/min * Proteinuria =\< grade 1 * No known or suspected history of impaired cardiac function as evidenced by baseline echocardiogram * Adequate pulmonary function * No history or clinical evidence of immune deficiency or autoimmunity * HIV negative * No history of or concurrent diagnosis of any of the following: * Altered immunodeficiency * Eczema or other eczematoid skin disorders * Acute, chronic, or exfoliative skin condition (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) * No history of allergy or untoward reaction to prior vaccination with vaccinia virus * No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * No history of allergy to eggs or egg products * No frequent vomiting or severe anorexia * No inflammatory bowel disease * No Crohn's disease * No ulcerative colitis * No active diverticulitis * Neuropathy =\< grade 1 (sensory neuropathy) * No uncontrolled seizure disorder * No encephalitis * No multiple sclerosis * Must be maintaining a reasonable state of nutrition (=\< 10 % weight loss in the past month) * Must be able to avoid close household contact (defined as sharing housing or having close physical contact) for at least 3 weeks after recombinant vaccinia vaccination with individuals with active or a history of eczema or other eczematoid skin disorders * Must be able to avoid close household contact (defined as sharing housing or having close physical contact) for at least 3 weeks after recombinant vaccinia vaccination with those with unresolved acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) * Must be able to avoid close household contact (defined as sharing housing or having close physical contact) for at least 3 weeks after recombinant vaccinia vaccination with any of the following individuals: pregnant or nursing women; children =\< 5 years of age; immunodeficient or immunosuppressed individuals (by disease or therapy), including HIV infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 6 months after study participation * No other concurrent serious medical illness that would preclude study participation * No concurrent biologic therapy * No other concurrent immunotherapy * At least 6 weeks since prior nitrosoureas or mitomycin * Prior docetaxel allowed (part I only) * No prior docetaxel (part II only) * No other concurrent chemotherapy * No concurrent systemic steroids except for the following: * physiologic doses for systemic steroid replacement therapy * local (topical, nasal, or inhaled) steroid use * no concurrent steroid eye drops * premedication prior to and after docetaxel * No concurrent hormonal therapy * No prior radiotherapy to \> 50 % of all nodal groups * More than 21 days since prior major surgery * No prior splenectomy * Recovered from prior therapy * At least 3-4 weeks since prior cytotoxic therapy


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
6 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Three weeks after treatment with vaccinia-CEA-TRICOM vaccine, patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC into each vaccination site on days 1-4.
Group II
Experimental
Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and lower-dose docetaxel IV over 30 minutes on days 1 and 8.
Group III
Experimental
Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and standard-dose docetaxel IV over 30 minutes on days 1 and 8.
Group IV
Experimental
Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and full-dose docetaxel IV over 1 hour on day 1.
Group 5
Experimental
Patients receive full-dose docetaxel IV over 1 hour on day 1, fowlpox-CEA-TRICOM vaccine SC on day 8, and GM-CSF SC into each vaccination site on days 8-11.
Group 6
Experimental
Patients receive full-dose docetaxel as in arm V, fowlpox-CEA-TRICOM vaccine SC on day 15, and GM-CSF SC into each vaccination site on days 15-18.
Study Objectives
Primary Objectives

The actual ELISPOT will be recorded for each individual and will be presented graphically.

Secondary Objectives

The impact of the combination therapy on CCC will be presented graphically with descriptive statistics. Will be plotted for each time point by each treatment group.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Lombardi Comprehensive Cancer Center at Georgetown UniversityWashington, United StatesSee the location

SuspendedOne Study Center