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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Graham Kelly, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

MEI Pharma, Inc.

Authority:

United States: Federal Government

Study ID:

CDR0000068802

NCT ID:

NCT00022295

Start Date:

August 2001

Completion Date:

October 2007

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195