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Treatment Of Patients With Metastatic Melanoma And Renal Cancer With A Combination Of Flt3L And CD40L


Phase 1
16 Years
N/A
Not Enrolling
Both
Kidney Cancer, Melanoma (Skin)

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Trial Information

Treatment Of Patients With Metastatic Melanoma And Renal Cancer With A Combination Of Flt3L And CD40L


OBJECTIVES: I. Determine the maximum tolerated dose of CD40-ligand when combined with
fixed-dose flt3 ligand in patients with metastatic melanoma or renal cell cancer.

OUTLINE: This is a dose-escalation study of CD40-ligand. Patients receive fixed-dose flt3
ligand subcutaneously (SC) daily on days 1-14 and CD40-ligand SC daily on days 12-16.
Treatment continues every 28 days for a maximum of 6 courses in the absence of unacceptable
toxicity or disease progression. Cohorts of 3 to 6 patients receive escalating doses of
CD40-ligand until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients
with progressive disease after 2 courses may be eligible to receive high-dose interleukin-2
(IL-2) standard therapy.

PROJECTED ACCRUAL: A total of 5 patients were accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell cancer or melanoma
Measurable disease

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-1 Life expectancy:
More than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least
90,000/mm3 No coagulation disorders Hepatic: Bilirubin no greater than 1.6 mg/dL AST and
ALT less than 2.5 times normal Hepatitis B surface antigen negative Renal: Creatinine no
greater than 2.0 mg/dL Cardiovascular: No major active medical illness of the
cardiovascular system (e.g., cardiac ischemia, myocardial infarction, or cardiac
arrhythmia) Pulmonary: No major active medical illness of the respiratory system (e.g.,
obstructive or restrictive pulmonary disease) Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception No active systemic
infections No history of autoimmune disorders HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy
No prior systemic flt3 ligand or CD40-ligand Chemotherapy: At least 3 weeks since prior
chemotherapy Endocrine therapy: At least 3 weeks since prior endocrine therapy No
concurrent systemic steroids Radiotherapy: Prior localized radiotherapy for renal cell
cancer or melanoma allowed Surgery: Prior surgery for renal cell cancer or melanoma
allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Patrick Hwu, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Surgery Branch

Authority:

United States: Federal Government

Study ID:

CDR0000068601

NCT ID:

NCT00020540

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Kidney Cancer
  • Melanoma (Skin)
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • stage IV melanoma
  • recurrent melanoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Melanoma

Name

Location

Surgery BranchBethesda, Maryland  20892