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

Melanoma (Skin) Clinical Trial

Official title:

Treatment of Patients With Metastatic Malignant Melanoma With Chemobiotherapy With Temozolomide, GM-CSF, IL2, and Interferon Alfa-2b Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00014092
• Other study ID #: CDR0000067958
• Secondary ID: SFMH-BB-IND-5301
• Status: Completed
• Phase: Phase 2
• First received: April 10, 2001
• Last updated: March 25, 2013
• Start date: December 1999
• Est. completion date: December 2003

Study information

• Verified date: March 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• aldesleukin

• recombinant interferon alfa

• sargramostim

Drug:
• temozolomide

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Aurora	Colorado
United States	Saint Francis Memorial Hospital	San Francisco	California
United States	John Wayne Cancer Institute at Saint John's Health Center	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Saint Francis Memorial Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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, interf — View Citation