Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

CI-980 in Treating Patients With Advanced Melanoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI UCCRC-8183 NCI-T96-0007H, T96-0007

Objectives

I.  Determine the objective response to CI-980 in patients with advanced 
melanoma.

II.  Describe the toxic effects of CI-980.

III.  Determine the duration of response, time to progression, and survival of 
these patients.

IV.  Characterize further the pharmacokinetic profile of CI-980.

Entry Criteria

Disease Characteristics:

Histologically verified melanoma that is metastatic or unresectable
  CNS metastasis allowed if controlled and asymptomatic following radiotherapy
  and/or surgery

Disease progression required if prior radiotherapy

Bidimensionally measurable disease on physical exam or x-ray with 1 lesion at
least 2 cm

No uncontolled CNS metastases

Prior/Concurrent Therapy:

No more than 1 prior immunotherapy or combined chemo-immunotherapy as adjuvant
therapy or for metastatic disease
  At least 4 weeks since immunotherapy or combined chemo-immunotherapy 

At least 3 weeks since radiotherapy or major surgery

Patient Characteristics:

Age:
  18 and over

Performance status:
  CALGB 0-2

Hematopoietic:
  WBC at least 3,000/mm3
  ANC at least 1,500/mm3
  Platelet count at least 100,000/mm3
  Hemoglobin at least 9.0 g/dL

Hepatic:
  Bilirubin no greater than 1.5 mg/dL (except with Gilbert's disease)
  AST no greater than 3 times normal
  Alkaline phosphatase no greater than 3 times normal

Renal:
  Creatinine no greater than 2.0 mg/dL

Neurologic:
  No prior history of neurologic disease, including:
     Stroke
     Transient ischemic attack
     Hallucination
     Seizure (unless related to controlled brain metastases)
     Other major neurologic problems

Other:
  No active infection
  No second malignancy within 5 years except nonmelanomatous skin cancer
  No prior metastatic disease except melanoma
  No medical or psychiatric condition that precludes study entry
  Not pregnant or nursing 
     Negative pregnancy test required of fertile women
  Adequate contraception required of fertile women
  Geographically accessible for follow-up

Expected Enrollment

A total of 37 patients will be entered if there is at least 1 complete 
response in the first 12 patients.

Outline

All patients receive CI-980 by continuous infusion over 72 hours, preferably 
through central venous access. Cycles will be repeated every 3 weeks.  Stable 
and responding patients receive at least 6 courses with further treatment at 
the discretion of the investigator.

Prophylactic antiemetics on the first course are discouraged.  Anticonvulsant 
therapy is not allowed.

Patients are followed for survival.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

Keith Shulman, MD, Protocol chair(Contact information may not be current)		Ph: 773-702-9200; 888-824-0200