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A Phase II Study Of CCI-779 (NSC 683864) In Metastatic Melanoma

Phase 2
18 Years
Not Enrolling
Melanoma (Skin)

Thank you

Trial Information

A Phase II Study Of CCI-779 (NSC 683864) In Metastatic Melanoma


- Determine the anti-tumor activity of CCI-779, in terms of progression-free survival, in
patients with metastatic melanoma.

- Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive CCI-779 IV over 30 minutes on day 1. Courses repeat every 7 days in the
absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: Approximately 40-50 patients will be accrued for this study within 12

Inclusion Criteria


- Histologically or cytologically confirmed metastatic melanoma that is incurable by
surgery, radiotherapy, or limb perfusion

- Measurable disease

- At least 20 mm by conventional techniques OR

- At least 10 mm by spiral CT scan

- The following are not considered measurable:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Abdominal masses not confirmed and followed by imaging techniques

- Cystic lesions

- Progressive disease

- No prior or concurrent CNS metastasis



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- More than 4 months


- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

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


- Bilirubin normal

- AST and ALT no greater than 2.5 times upper limit of normal

- Cholesterol no greater than 350 mg/dL (lipid-lowering therapy allowed)

- Triglycerides no greater than 300 mg/dL except for hydroxymethyl-glutaryl-coenzyme A
reductase inhibitors


- Creatinine normal OR

- Creatinine clearance at least 60 mL/min


- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No prior allergic reactions to compounds of similar chemical or biological
composition to study drug

- No ongoing or active infection

- No seizure disorder

- No autoimmune disease

- No psychiatric illness or social situation that would preclude study

- No other concurrent uncontrolled illness that would preclude study


Biologic therapy:

- No more than 1 prior adjuvant biological therapy regimen

- No more than 1 prior biological therapy regimen for advanced disease

- At least 6 months since prior biological therapy or biochemotherapy and recovered

- Prior isolated limb perfusion with biological agent allowed if not to sole site of


- See Biologic therapy

- Prior isolated limb perfusion with chemotherapy allowed if not to sole site of

- No more than 1 prior chemotherapy-containing regimen for advanced disease, regardless
of adjuvant therapy

- May be in addition to 1 prior biologic regimen for advanced disease OR

- May have had 1 prior biochemotherapy regimen for advanced disease

- At least 3 weeks since prior chemotherapy and recovered

Endocrine therapy:

- At least 1 week since prior dexamethasone

- No concurrent glucocorticosteroid therapy


- See Disease Characteristics


- See Disease Characteristics


- At least 1 week since prior phenobarbital, phenytoin, carbamazepine, or rifampin

- At least 3 weeks since other prior agents to treat malignancy

- At least 3 weeks since prior investigational agents

- No other concurrent investigational agents

- No concurrent drugs that are metabolized by or alter the level of cytochrome P450-3A

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Kim A. Margolin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute


United States: Federal Government

Study ID:




Start Date:

June 2001

Completion Date:

Related Keywords:

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



University of Chicago Cancer Research Center Chicago, Illinois  60637
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Loyola University Medical Center Maywood, Illinois  60153
Ingalls Memorial Hospital Harvey, Illinois  60426
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
North Shore University Hospital Manhasset, New York  11030
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
University of California Davis Cancer Center Sacramento, California  95817
City of Hope Comprehensive Cancer Center Duarte, California  91010
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
Fort Wayne Medical Oncology and Hematology, Incorporated Fort Wayne, Indiana  46885-5099
Weill Medical College of Cornell University New York, New York  10021
Evanston Northwestern Health Care - Evanston Hospital Evanston, Illinois  60201
Oncology/Hematology Associates of Central Illinois, P.C. Peoria, Illinois  61602
Central Illinois Hematology Oncology Center Springfield, Illinois  62701
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
City of Hope Medical Group Pasadena, California  91105
LaGrange Memorial Hospital LaGrange, Illinois  60525