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


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Lynn E. Spitler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Northern California Melanoma Center at St. Francis Memorial Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000067958

NCT ID:

NCT00014092

Start Date:

December 1999

Completion Date:

December 2003

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
John Wayne Cancer Institute at Saint John's Health CenterSanta Monica, California  90404
Saint Francis Memorial HospitalSan Francisco, California  94109