XK469 in Treating Patients With Advanced Solid Tumors

NCT00028548 | Completed Phase 1 DMC

• 6 other identifiers: CDR0000069103U01CA062487P30CA022453WSU-C-2346NCI-4550WSU-T-2001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Arms (1)

XK469

EXPERIMENTAL

Drug: R(+)XK469

Interventions

R(+)XK469 DRUG

XK469

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Interventions

XK 469

Study Officials

• Patricia M. LoRusso, DO

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2002
• First Posted: January 27, 2003
• Study Start: January 1, 2002
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: April 25, 2014

Record last verified: 2014-04

Locations

US (1)