Phenoxodiol in Treating Patients With Refractory Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00022295
First received: August 10, 2001
Last updated: March 25, 2013
Last verified: March 2007
  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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 36
Study Start Date: August 2001
Study Completion Date: October 2007
Detailed Description:

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
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022295

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Novogen
Investigators
Study Chair: Graham Kelly, PhD MEI Pharma, Inc.
  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 October 22, 2014