Phenoxodiol in Treating Patients With Refractory Solid Tumors
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Purpose
RATIONALE: Phenoxodiol may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase I trial to study the effectiveness of phenoxodiol in treating patients who have refractory solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: idronoxil |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase IB Study of Phenoxodiol Given by Constant Intravenous Infusion in Patients With Solid Neoplasms (With the Exception of Breast Cancer) Whose Tumors Are Refractory to Standard Therapy |
| Estimated Enrollment: | 36 |
| Study Start Date: | August 2001 |
| Study Completion Date: | October 2007 |
OBJECTIVES:
- Determine the maximum tolerated dose of phenoxodiol in patients with refractory solid tumors.
- Determine the steady-state pharmacokinetics of this drug in these patients.
- Determine the tumor response in patients treated with this drug.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive phenoxodiol IV continuously over days 1-7. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of phenoxodiol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: Approximately 18-36 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumor
- Refractory to standard therapy OR
- No standard therapy exists
- No breast cancer
No active CNS metastases
- Known CNS metastases must be previously treated with radiotherapy or surgery and stable for at least 4 weeks prior to study
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 3 months
Hematopoietic:
- Platelet count greater than 100,000/mm^3
- WBC greater than 3,000/mm^3
- Neutrophil count greater than 1,500/mm^3
- Hemoglobin greater than 10 g/dL (9 g/dL for women)
Hepatic:
- Bilirubin less than 1.2 mg/dL
- Transaminases no greater than 3 times upper limit of normal
Renal:
- Creatinine no greater than 1.4 mg/dL
Other:
- No active infection
- No contraindication to the insertion of a vascular access device
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent systemic anticancer immunotherapy
Chemotherapy:
- No concurrent systemic anticancer chemotherapy
Endocrine therapy:
- No concurrent systemic anticancer hormonal therapy except luteinizing hormone-releasing hormone agonists or antagonists
Radiotherapy:
- See Disease Characteristics
- Concurrent localized radiotherapy for control of local disease complications allowed
Surgery:
- See Disease Characteristics
Other:
- Recovered from prior antineoplastic therapy
- At least 4 weeks since prior investigational agents
- No other concurrent investigational drugs
Contacts and Locations
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00022295 History of Changes |
| Other Study ID Numbers: | CDR0000068802, NOVOGEN-NV06-0024, CCF-4269, NCI-V01-1663 |
| Study First Received: | August 10, 2001 |
| Last Updated: | March 25, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on June 17, 2013