Phenoxodiol in Treating Patients With Refractory Solid Tumors
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00022295 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : March 26, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific | Drug: idronoxil | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
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 |
Study Start Date : | August 2001 |
Actual Study Completion Date : | October 2007 |


Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022295
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 |
Study Chair: | Graham Kelly, PhD | MEI Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00022295 |
Other Study ID Numbers: |
CDR0000068802 NOVOGEN-NV06-0024 CCF-4269 NCI-V01-1663 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | March 26, 2013 |
Last Verified: | March 2007 |
unspecified adult solid tumor, protocol specific |
Neoplasms |