Status:
WITHDRAWN
Interleukin-2 and Sargramostim After Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Interleukin-2 and sargramostim may stimulate a person's white blood cells to kill melanoma cells. PURPOSE: This phase II trial is studying how well giving interleukin-2 together with sargr...
Detailed Description
OBJECTIVES: Primary * Determine the frequency of complete response in patients with stage III or IV melanoma who have achieved either a partial response or stable disease after prior systemic chemot...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed melanoma
- Stage III or IV disease
- No primary ocular melanoma
- Stable disease (SD) or partial response (PR) after prior systemic chemotherapy completed at least 4 weeks ago
- Patients whose second post-chemotherapy evaluation (performed at least 4 weeks after the first evaluation that demonstrated SD or PR AND within 2 weeks before study entry) of disease demonstrates continued tumor shrinkage are not eligible
- Patients whose second evaluation shows disease progression are eligible unless one of the following is true:
- Lactic dehydrogenase (LDH) ≥ 2 times upper limit of normal (ULN)
- LDH \> ULN AND is higher than the patient's highest value before systemic chemotherapy
- Patient has developed a new tumor measuring \> 1 cm in diameter
- Sum of the longest diameters of the existing tumor has increased \> 20%
- Evaluable or measurable disease
- Not potentially curable by surgery
- No active CNS metastases
- Solitary brain metastasis allowed if completely resected or completely ablated with radiosurgery more than 1 month before study entry
- PATIENT CHARACTERISTICS:
- Age
- 16 and over
- Performance status
- Karnofsky 60-100%
- Life expectancy
- Not specified
- Hematopoietic
- WBC ≥ 3,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- No active bleeding
- Hepatic
- See Disease Characteristics
- Bilirubin ≤ 2.0 mg/dL
- Renal
- Creatinine ≤ 1.2 mg/dL
- Cardiovascular
- Patients ≥ 50 years of age OR those with one or more cardiac risk factors must demonstrate one of the following:
- Normal exercise stress test
- Normal stress thallium test
- Normal comparable cardiac ischemia evaluation
- LVEF ≥ 40%
- Other
- No active infection requiring treatment
- No concurrent medical or psychiatric condition that would increase the potential toxicity of study treatment
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No other concurrent antineoplastic biologic response modifier therapy
- No concurrent antineoplastic vaccine therapy
- Chemotherapy
- See Disease Characteristics
- No concurrent antineoplastic chemotherapy
- Endocrine therapy
- No concurrent steroidal antiemetics
- No concurrent systemic corticosteroids
- Radiotherapy
- See Disease Characteristics
- No concurrent antineoplastic radiotherapy
- Surgery
- See Disease Characteristics
- Recovered from prior surgery
- Surgery within the past 4 weeks allowed provided there is no evidence of disease progression
- Other
- More than 4 weeks since prior therapy for melanoma
- No other concurrent antineoplastic experimental therapy
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00085579
Start Date
March 1 2004
End Date
March 1 2005
Last Update
December 12 2012
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021