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Interleukin-2 and Sargramostim After Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Melanoma (Skin)

Intervention: aldesleukin (Biological); sargramostim (Biological); adjuvant therapy (Procedure)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Paul B. Chapman, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center
Jedd D. Wolchok, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

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 sargramostim works in treating patients with stage III or stage IV melanoma that was previously treated with chemotherapy.

Clinical Details

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

Study design: Masking: Open Label, Primary Purpose: Treatment

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 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

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States
Additional Information

Starting date: March 2004
Last updated: December 11, 2012

Page last updated: August 23, 2015

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