Completed

PHASE I STUDY OF INTERFERON ENHANCED INTRAPERITONEAL RADIOIMMUNO-CHEMOTHERAPY FOR OVARIAN CANCER

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What is being tested

recombinant interferon alfa

+ chemotherapy

+ paclitaxel

BiologicalDrugRadiation
Who is being recruted

Urogenital Diseases+16

+ Genital Diseases

+ Adnexal Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: March 1996
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: February 5, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1996

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of intraperitoneal paclitaxel and topotecan when administered as a radiosensitizer prior to intraperitoneal lutetium Lu 177 monoclonal antibody CC49 (177Lu-CC49) following subcutaneous interferon alfa-2b (IFN-A) in patients with persistent or recurrent ovarian cancer. II. Determine the toxicity associated with intraperitoneal paclitaxel and topotecan in these patients. III. Examine the conjugate stability, pharmacokinetics, and biodistribution of 177Lu-CC49 given 48 hours after intraperitoneal paclitaxel. IV. Determine the effects of IFN-A and intraperitoneal paclitaxel on 177Lu-CC49 tumor localization and dosimetry estimates compared to a prior trial with 177Lu-CC49 alone. V. Determine the MTD of yttrium Y 90 monoclonal antibody CC49 (90Y-CC49) when administered with IFN-A and the dose of paclitaxel used at the MTD level of IFN-A, paclitaxel, and 177Lu-CC49. VI. Monitor any antitumor effects of this treatment in these patients. OUTLINE: This is a dose escalation study of paclitaxel, topotecan, lutetium LU 177 monoclonal antibody CC-49 (177Lu-CC49), and yttrium Y 90 monoclonal antibody CC49 (90Y-CC49). Patients receive interferon alfa subcutaneously on days 1, 3, 5, and 7; paclitaxel intraperitoneally (IP) on day 4 or topotecan IP on day 6; and 177Lu-CC49 IP on day 6. Treatment continues every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-5 patients receive escalating doses of paclitaxel and decreasing doses of 177Lu-CC49 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 5 patients experience dose limiting toxicity. Once the MTD of paclitaxel is determined, the dose of 177Lu-CC49 is escalated. Once the MTD of 177Lu-CC49 is determined, 90Y-CC49 is substituted. The MTD of 90Y-CC49 is then determined when administered with paclitaxel. Topotecan is then substituted for paclitaxel (administered with the MTD of 177Lu-CC49 and interferon alfa only) and escalated until the MTD is determined. Patients are followed at 6 weeks and then every 3 months for 1 year.

NCT00002734
Principal SponsorNational Cancer Institute (NCI)
Last updated: February 5, 2013
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

30 patients to be enrolled

Total 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.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesCarcinomaEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOvarian DiseasesUrogenital NeoplasmsFemale Urogenital DiseasesCarcinoma, Ovarian EpithelialOvarian Neoplasms

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the ovary or papillary serous carcinoma of extraovarian origin Recurrent or persistent following standard surgery and 1 or 2 chemotherapy regimens (with or without paclitaxel), i.e.: persistent disease or progression after chemotherapy with nodules less than the equivalent of 5 x 5 x 5 cm Recurrent carcinoma (after primary or secondary chemotherapy) detected clinically either by exam or rising CA 125 and with radiographic evidence of disease no greater than the equivalent of 5 x 5 x 5 cm nodules Residual disease less than 5 x 5 x 5 cm following reassessment laparotomy Microscopic residual disease on reassessment laparotomy after chemotherapy Tumor TAG-72 positive by immunoperoxidase staining of original or current tumor blocks At least 85% free flow of fluid in peritoneal cavity demonstrated by technetium-99m scan or other imaging within 2 weeks prior to treatment No evidence of disease outside the peritoneal cavity other than retroperitoneal lymphadenopathy No massive ascites PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 WBC at least 3,500/mm3 Platelet count at least 125,000/mm3 Hemoglobin greater than 9 g/dL No nucleated RBC or significant teardrop RBC morphology Bilirubin less than 1.5 mg/dL AST/ALT less than 4 times normal Creatinine less than 2.0 mg/dL HIV negative Hepatitis B surface antigen negative No hypersensitivity to paclitaxel, polyoxethylated castor oil, or topotecan No other malignancy in past 5 years except basal cell skin carcinoma Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: At least 3 weeks since prior biologic therapy and recovered No prior monoclonal antibody therapy No concurrent immunotherapy No prior bone marrow or stem cell transplantation At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered No concurrent chemotherapy At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to the abdominal cavity No concurrent radiotherapy At least 3 weeks since prior major surgery and recovered No prior intraperitoneal therapy

Study Plan

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

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive interferon alfa subcutaneously on days 1, 3, 5, and 7; paclitaxel intraperitoneally (IP) on day 4 or topotecan IP on day 6; and 177Lu-CC49 IP on day 6. Treatment continues every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-5 patients receive escalating doses of paclitaxel and decreasing doses of 177Lu-CC49 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 5 patients experience dose limiting toxicity. Once the MTD of paclitaxel is determined, the dose of 177Lu-CC49 is escalated. Once the MTD of 177Lu-CC49 is determined, 90Y-CC49 is substituted. The MTD of 90Y-CC49 is then determined when administered with paclitaxel. Topotecan is then substituted for paclitaxel (administered with the MTD of 177Lu-CC49 and interferon alfa only) and escalated until the MTD is determined.

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

University of Alabama Comprehensive Cancer Center

Birmingham, United StatesOpen University of Alabama Comprehensive Cancer Center in Google Maps
CompletedOne Study Center