XK469 in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of XK469 in treating patients who have advanced solid tumors.

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

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-hematological cancer that is unresponsive to available therapies or for which there is no known effective treatment

• Measurable or evaluable disease

• Clinical or radiological evidence of disease required

• No active brain metastases

PATIENT CHARACTERISTICS:

Age:

• 16 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Absolute neutrophil count at least 2,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• ALT and AST no greater than 2.5 times upper limit of normal

Renal:

• Creatinine less than 1.5 mg/dL

Cardiovascular:

• Ejection fraction at least 50%

• No significant arrhythmias

• No congestive heart failure

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No dementia or altered mental status

• No known HIV infection

• No active infection

• No other serious uncontrolled medical disorder that would preclude study participation

• No known allergies to soy products, rice flour, or gelatin (if receiving study dietary soy supplementation)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy

• No concurrent prophylactic colony-stimulating factors

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

• Prior taxanes allowed

• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy except hormone replacement therapy or medication used to maintain castrate status for patients with progressive hormone-refractory prostate cancer

Radiotherapy:

• At least 4 weeks since prior radiotherapy

• No prior radiotherapy to more than 25% of bone marrow-containing areas

• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• At least 4 weeks since prior investigational agents

• No other concurrent experimental anticancer therapy