Completed

SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas

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What is being tested

semaxanib

Drug
Who is being recruted

Gastrointestinal Stromal Tumor

+ Sarcoma
Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2000

See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: February 11, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2000Actual date on which the first participant was enrolled.

Phase II trial to study the effectiveness of SU5416 in treating patients who have advanced, metastatic, or recurrent soft tissue sarcomas. SU5416 may stop the growth of soft tissue sarcomas by stopping blood flow to the tumor. OBJECTIVES: I. Determine the response rate, response duration, and overall survival in patients with advanced, metastatic, or recurrent soft tissue sarcoma or gastrointestinal stromal tumor when treated with SU5416. II. Determine the safety of SU5416 in these patients. OUTLINE: This is a multicenter study. Patients receive SU5416 IV twice weekly for 4 weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 3 months and then every 3 months for 1 year.

Official TitleA Phase II Trial of SU5416 (NSC #696819) in Previously Treated Patients With Advanced, Metastatic and/or Locally Recurrent Soft Tissue Sarcomas 
Principal SponsorNational Cancer Institute (NCI)
Last updated: February 11, 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
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, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different 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
Gastrointestinal Stromal Tumor
Sarcoma
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed advanced, metastatic, recurrent, or unresectable soft tissue sarcoma or gastrointestinal stromal tumor * Measurable disease defined as lesions that can be measured in at least one dimension as at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan * Must have received prior chemotherapy with no response or progression after initial response * Evidence of disease progression in past 3 months * No CNS metastases or primary brain tumors PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: ECOG 0-1 * Life expectancy: At least 12 weeks * WBC greater than 2,000/mm3 * Platelet count greater than 100,000/mm3 * Fibrin split products no greater than 0.001 mg * Fibrinogen greater than 200 mg/dL * Bilirubin no greater than upper limit of normal (ULN) * AST/ALT less than 1.5 times ULN * PT/PTT less than 1.25 times ULN * Creatinine no greater than 1.5 mg/dL * At least 1 year since bypass surgery for atherosclerotic coronary artery disease * No uncompensated coronary artery disease * No history of myocardial infarction or unstable/severe angina in past 6 months * No severe peripheral vascular disease * No history of deep venous or arterial thrombosis in past 3 months * No history of pulmonary embolism in past 3 months * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No diabetes mellitus * No history of bleeding diathesis * No known active retroviral disease * No AIDS-associated Kaposi's sarcoma * No history of allergic reaction to Cremophor or paclitaxel * No uncontrolled illness or psychiatric disorder that would preclude study PRIOR CONCURRENT THERAPY: * No concurrent immunotherapy * At least 3 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) * No concurrent chemotherapy * At least 3 weeks since prior radiotherapy * No concurrent radiotherapy * Greater than 2 weeks since prior minor surgery (greater than 4 weeks since major surgery) * No concurrent antiinflammatory drugs

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
atients receive SU5416 IV twice weekly for 4 weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.

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 2 locations
Suspended
Massachusetts General Hospital Cancer CenterBoston, United StatesSee the location
Suspended
Dana-Farber Cancer InstituteBoston, United States
Completed2 Study Centers