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Phase II Study of Outpatient CDDP and DTIC Followed by GM-CSF, IFN-a2b, and IL-2 in Patients With Advanced Melanoma


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

Thank you

Trial Information

Phase II Study of Outpatient CDDP and DTIC Followed by GM-CSF, IFN-a2b, and IL-2 in Patients With Advanced Melanoma


OBJECTIVES:

- Determine the toxicity of cisplatin and dacarbazine followed by sargramostim (GM-CSF),
interferon alfa, and interleukin-2 in patients with metastatic melanoma.

- Determine the objective response rate, relapse free survival, and overall survival of
these patients on this regimen.

OUTLINE: Patients receive cisplatin IV over 1 hour and dacarbazine IV over 30-60 minutes
sequentially on day 1, followed by sargramostim (GM-CSF) subcutaneously (SC) on days 2-7,
interleukin-2 SC on days 8-14, and interferon alfa SC on days 8, 10, 12, and 14. Treatment
repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 8 weeks until disease progression, and then every 8-12 weeks
thereafter.

PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic melanoma

- Stage III with intransit metastases

- Stage IV

- No uncontrolled brain metastases by CT scan

- No clinically significant ascites or pleural effusions

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- Karnofsky 70-100%

Life expectancy:

- At least 10 weeks

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9.5 g/dL

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- SGOT no greater than 4 times upper limit of normal

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 70 mL/min

Cardiovascular:

- No clinically significant cardiac disease on EKG, echocardiogram, or MUGA scan

Pulmonary:

- No clinically significant pulmonary disease on chest x-ray

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No significant thyroid dysfunction

- No concurrent severe infection

- No other medical or psychiatric condition that would interfere with compliance

- No second malignancy within the past 5 years, except:

- Localized nonmelanomatous skin cancer

- Carcinoma in situ of the cervix

- Grade 1 Ta bladder cancer

- Suspected hearing deficits must undergo audiologic testing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No more than one prior immunotherapy regimen

- At least 4 weeks since prior immunotherapy

- Adjuvant interferon alfa before relapse allowed

Chemotherapy:

- No more than one prior chemotherapy regimen

- At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas)

- No concurrent cyclophosphamide

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent corticosteroids or cyclosporine A

Radiotherapy:

- At least 2 weeks since prior radiotherapy

Surgery:

- At least 3 weeks since major surgery

Other:

- No concurrent immunosuppressive drugs

- No other concurrent investigational antineoplastic drugs

- Concurrent thyroid replacement therapy allowed

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Thomas F. Gajewski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

9372

NCT ID:

NCT00004141

Start Date:

August 1998

Completion Date:

April 2006

Related Keywords:

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

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637