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| Sponsor: | Barbara Ann Karmanos Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00028548 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: R(+)XK469 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Study of R(+)-XK469 (NSC 698215) Given Daily, Days 1-5, Repeated Every Three Weeks in Patients With Advanced Malignancies |
| Study Start Date: | January 2002 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive XK469 IV over 20 minutes on days 1-5. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of XK469 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of the first 6 patients experience dose-limiting toxicity.
Once the MTD is determined, up to 15 patients are treated at that dose. Patients in the expanded MTD cohort also receive oral NovaSoy® soybean extract twice daily for the study duration.
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: Approximately 25-40 patients will be accrued for this study within 12-15 months.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Study Chair: | Patricia M. LoRusso, DO | Barbara Ann Karmanos Cancer Institute |
More Information
| Study ID Numbers: | CDR0000069103, WSU-C-2346, NCI-4550, WSU-T-2001 |
| Study First Received: | January 4, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00028548 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific |