Completed

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

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What is being tested

Cisplatin

+ dacarbazine

+ Granulocyte-macrophage colony-stimulating factor

Drug
Who is being recruted

Neoplasms+9

+ Neoplasms by Histologic Type

+ Neoplasms by Site

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 1998
See protocol details

Summary

Principal SponsorUniversity of Chicago
Last updated: September 5, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00004141
Principal SponsorUniversity of Chicago
Last updated: September 5, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

46 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin DiseasesSkin NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine TumorsMelanoma

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
CDDP (75 mg/m2) and DTIC (660 mg/m2) will be administered sequentially by intravenous infusion in day 1. Subsequently, GM-CSF (450 mg/ m2) will be administered SC days 2-7; IL-2 (11 MU daily) will be given SC days 8-14, and IFN-2b (9 MU) will be given SC days 8, 10, 12, and 14.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Chicago Cancer Research Center

Chicago, United StatesOpen University of Chicago Cancer Research Center in Google Maps
CompletedOne Study Center