Phenoxodiol in Treating Patients With Refractory Solid Tumors

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kazia Therapeutics Limited; Novogen Ltd

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