Overview

Decitabine in Treating Patients With Advanced Solid Tumors

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
This phase I trial is studying the side effects and best dose of decitabine in treating patients with advanced solid tumors that have not responded to previous treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Azacitidine
Decitabine
Criteria
Inclusion Criteria:

- Diagnosis of advanced metastatic solid tumor for which all standard therapy has
failed, including, but not limited to the following:

- Stage III or IV melanoma

- Mucosal melanoma allowed

- No resectable stage III melanoma

- Bladder cancer

- Breast cancer

- No active symptomatic CNS disease

- No radiographically evident cerebral edema

- Hormone receptor status:

- Not specified

- Male or female

- Performance status - ECOG 0-1

- Hemoglobin at least 9.0 g/dL

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

- WBC at least 3,500/mm^3

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

- No coagulation disorders

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT and SGPT less than 2.5 times ULN

- Hepatitis B surface antigen negative

- Hepatitis C antibody negative

- Creatinine no greater than 1.5 times ULN

- No major cardiovascular system illness

- No major respiratory system illness

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No major systemic infection

- At least 1 month since prior radiotherapy

- At least 1 month since any prior anticancer therapy or adjuvant therapy

- No other experimental treatment within 30 days prior to, during, and for 30 days after
study therapy