Interleukin-2 and Sargramostim After Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma
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Purpose
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 sargramostim works in treating patients with stage III or stage IV melanoma that was previously treated with chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: aldesleukin Biological: sargramostim Procedure: adjuvant therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Maintenance Biotherapy With Interleukin-2 and Granulocyte-Macrophage Colony Stimulating Factor in Patients With Metastatic Melanoma With a Partial Response or Stable Disease After Systemic Therapy |
| Enrollment: | 0 |
| Study Start Date: | March 2004 |
| Study Completion Date: | March 2005 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
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 chemotherapy and are treated with maintenance biotherapy comprising interleukin-2 and sargramostim (GM-CSF).
Secondary
- Determine the time to progression in patients treated with this regimen.
- Determine the effects of this regimen on lymphocyte subsets in these patients.
OUTLINE: Patients are stratified according to response to prior systemic chemotherapy (stable disease [SD] vs partial response [PR]).
Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-14 and low-dose interleukin-2 (IL-2) SC on days 1-5, 8-12, 15-19, and 22-26. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive pulses of high-dose IL-2* IV continuously over 42 hours on days 1 and 2 of courses 2, 3, 5, 6, 8, 10 and 12.
NOTE: *Low-dose IL-2 and GM-CSF are not administered on days 1 and 2 of high-dose IL-2 administration
Patients who continue to have SD or a PR after 12 courses of therapy may continue to receive treatment with GM-CSF and low-dose IL-2 as described above and high-dose IL-2 on days 1 and 2 of every third course.
PROJECTED ACCRUAL: A total of 20-58 patients (10-29 per stratum) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | Paul B. Chapman, MD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Jedd D. Wolchok, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00085579 History of Changes |
| Other Study ID Numbers: | 04-027, MSKCC-04027 |
| Study First Received: | June 10, 2004 |
| Last Updated: | December 11, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
stage III melanoma stage IV melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Aldesleukin Interleukin-2 Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 23, 2013