Status:
COMPLETED
A Pilot Trial of Oral Topotecan for the Treatment of Refractory Advanced Solid Neoplasms Expressing HIF-1a
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Background: HIF-1 is a common mediator of hypoxic and non-hypoxic pathways that affects a transcriptional program leading to survival, angiogenesis, migration and invasion of cancer cells. We have de...
Detailed Description
Background: HIF-1 is a common mediator of hypoxic and non-hypoxic pathways that affects a transcriptional program leading to survival, angiogenesis, migration and invasion of cancer cells. We have de...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients must have a pathologically confirmed solid tumor that is metastatic or unresectable and which has either progressed following standard therapy or for which there is no recommended standard treatment.
- Patients must have tumors that can be biopsied with a minimal to small amount of risk and must have a malignancy that expresses HIF-1 alpha protein as measured by immunohistochemistry (determined on archival tissue, at least greater than 10% of cells show positive staining for HIF-1 alpha).
- ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
- Life expectancy is greater than 3 months.
- Age greater than or equal to 18 years.
- Patients must have normal organ and marrow functions as defined below.
- leukocytes greater than or equal to 3000/mm(3).
- absolute neutrophils greater than or equal to 1500/mm(3).
- platelets greater than or equal to 100,000/mm(3).
- AST (SGOT)/ALT (SGPT) less than or equal to 2.5 x institutional upper limit of normal.
- total bilirubin less than or equal to 1.5x institutional upper limit of normal.
- Serum Creatinine less than or equal to 1.5 mg/dL OR creatinine clearance greater than or equal to 50 mL/min for patients with creatinine levels greater than 1.5 mg/dL.
- PT/PTT less than or equal to 1.5 x ULN.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
- No unstable medical illness.
- Ability to understand and the willingness to sign a written informed consent document.
- EXCLUSION CRITERIA:
- Patients who have had anticancer therapy (chemotherapy, radiotherapy, vaccines and hormone therapy with the exception of GnRH agonists) within the last 4 weeks (6 weeks for nitrosoureas or mitomycin C or UCN-01); or those who have not recovered from adverse events (reduce to grade 2 or less) due to agents administered more than 4 weeks earlier. Patients must be greater than or equal to 2 weeks since any investigational agent administered as part of a Phase 0 study.
- Prior therapy with topotecan.
- Patients may not be receiving any other investigational agents. Patients who are on androgen suppression for the treatment of prostate cancer are eligible and will be allowed to continue the androgen suppression therapy on study. No herbal/alternative medications will be allowed on this study other than one multivitamin a day.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. However, patients who have had treatment for their brain metastases and whose brain metastatic disease has remained stable for at least 4 months without steroids or anti-seizure medications may be enrolled at the discretion of the Principal Investigator.
- History of allergic reaction attributed to compounds of similar chemical or biologic composition to topotecan or history of allergic reaction to any component of the topotecan formulation.
- Active peptic ulcer or GI condition that could alter absorption or motility.
- Pregnant women are excluded from this study. Breastfeeding should be discontinued if the mother is treated with topotecan.
- Patients with known immune deficiency syndromes or who are HIV positive will be excluded from the study.
Exclusion
Key Trial Info
Start Date :
June 28 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00117013
Start Date
June 28 2005
End Date
October 25 2010
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892