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

NCT00085579 | Withdrawn Phase 2

• 2 other identifiers: 04-027MSKCC-04027
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma

Interventions

aldesleukin BIOLOGICAL

sargramostim BIOLOGICAL

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin; sargramostim; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Paul B. Chapman, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Jedd D. Wolchok, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: March 1, 2004
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: December 12, 2012

Record last verified: 2012-12

Locations

US (1)