Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery

NCT ID: NCT00014092

Last Updated: 2013-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-12-31
• Study Completion Date: 2003-12-31

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interleukin-2 and interferon alfa stimulate a person's white blood cells to kill cancer cells or may interfere with the growth of cancer cells. Combining chemotherapy with biological therapies may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by sargramostim, interleukin-2, and interferon alfa in treating patients who have stage IV melanoma that cannot be treated with surgery.

Detailed Description

OBJECTIVES:

• Determine the response rate, time to progression, and survival of patients with unresectable stage IV melanoma treated with temozolomide followed by sargramostim (GM-CSF), interleukin-2, and interferon alfa.
• Determine the safety and tolerability of this regimen in this patient population.
• Determine the changes in quality of life over time in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral temozolomide on days 1-5, and sargramostim (GM-CSF), interleukin-2, and interferon alfa subcutaneously on days 6-17. Treatment repeats every 28 days for 4-8 courses in the absence of disease progression or unacceptable toxicity. Patients with at least stable or responsive disease after 8 courses of therapy may receive additional therapy at investigators discretion.

Quality of life is assessed at baseline, every 8 weeks during study, and then at 1 month after study.

Patients are followed at 1 month, every 3 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 2 years.

Conditions

Melanoma (Skin)

Study Design

• Primary Study Purpose: TREATMENT

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

recombinant interferon alfa

Intervention Type: BIOLOGICAL

sargramostim

Intervention Type: BIOLOGICAL

temozolomide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed unresectable stage IV melanoma
• Measurable metastatic disease
• No uncontrolled brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• More than 12 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT and SGPT no greater than 3 times ULN
• Alkaline phosphatase no greater than 3 times ULN

Renal:

• BUN no greater than 1.5 times ULN
• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No significant cardiovascular disease

Other:

• No non-malignant systemic disease
• No acute infection requiring IV antibiotics
• No alcohol or substance abuse
• No other condition, disease, or history of other illness that would preclude study participation
• No hypersensitivity, allergic reactions, or intolerance to study drugs
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy
• No prior interleukin-2
• No other concurrent immunotherapy
• No concurrent investigational vaccines or immunomodulatory agents
• No other concurrent growth factors

Chemotherapy:

• At least 4 weeks since prior chemotherapy
• No prior temozolomide
• No other concurrent anticancer chemotherapy

Endocrine therapy:

• No concurrent steroids (including corticosteroids)

Radiotherapy:

• At least 4 weeks since prior radiotherapy

Surgery:

• See Disease Characteristics
• At least 3 weeks since prior major surgery

Other:

• At least 30 days since prior immune-based therapy
• No concurrent participation in other clinical trials with investigational drugs
• No other concurrent anticancer drugs
• No concurrent immunosuppressive therapy
• No concurrent levamisole or cimetidine

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint Francis Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Lynn E. Spitler, MD

Role: STUDY_CHAIR

Northern California Melanoma Center at St. Francis Memorial Hospital

Locations

Saint Francis Memorial Hospital

San Francisco, California, United States

John Wayne Cancer Institute at Saint John's Health Center

Santa Monica, California, United States

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, Colorado, United States

Countries

United States

References

Weber RW, O'Day S, Rose M, Deck R, Ames P, Good J, Meyer J, Allen R, Trautvetter S, Timmerman M, Cruickshank S, Cook M, Gonzalez R, Spitler LE. Low-dose outpatient chemobiotherapy with temozolomide, granulocyte-macrophage colony stimulating factor, interferon-alpha2b, and recombinant interleukin-2 for the treatment of metastatic melanoma. J Clin Oncol. 2005 Dec 10;23(35):8992-9000. doi: 10.1200/JCO.2005.02.5791. Epub 2005 Oct 31.

Reference Type: RESULT

PMID: 16260693 (View on PubMed)

Other Identifiers

SFMH-BB-IND-5301

Identifier Type: -

Identifier Source: secondary_id

NCI-V00-1591

Identifier Type: -

Identifier Source: secondary_id

CDR0000067958

Identifier Type: -

Identifier Source: org_study_id