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

NCT ID: NCT00085579

Last Updated: 2012-12-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2005-03-31

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

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.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

sargramostim

Intervention Type: BIOLOGICAL

adjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Paul B. Chapman, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Jedd D. Wolchok, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

MSKCC-04027

Identifier Type: -

Identifier Source: secondary_id

04-027

Identifier Type: -

Identifier Source: org_study_id