Clinical trial · Interventional
Decitabine in Treating Patients With Advanced Solid Tumors
A Phase I Study Of The Toxicities, Biologic And Clinical Effects Of Daily 5 Aza 2'Deoxycytidine (DAC), NSC 127716 (IND 50733) For Four Weeks In Patients With Advanced Malignancies
NCT00030615CI-TRIAL-00009347completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Male Breast Cancer | Male Breast Carcinoma | ALIAS | 0.90 |
| Recurrent Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Stage III Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Stage IV Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| decitabine | Drug | Decitabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (decitabine)
- description
- Patients receive decitabine IV over 30 minutes on days 1-5 weekly for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of decitabine until the MTD is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- interventionNames
- Drug: decitabine
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Maximum tolerated dose determined by dose-limiting toxicities graded according to CTC 2.0 toxicity criteria
- timeFrame
- 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.