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Clinical Trial Spotlight
Solid Tumor – NCI-05-C-0186

Dr. Shivaani Kummar
Principal Investigator

NCI is currently conducting the following trial for patients with solid tumors. Click on the trial below for additional details, including a summary of eligibility criteria, treatment plan, and information on how to contact Dr. Kummar and her staff directly.

You may also call the Clinical Trials Referral Office at 1-888-NCI-1937 (1-888-624-1937) to inquire about referring a patient to this trial.

A Pilot Trial of Oral Topotecan for the Treatment of Refractory Advanced Solid Neoplasms Expressing HIF-1alpha
NCI-05-C-0186

  • Patients receive oral topotecan daily for 2 consecutive weeks (5 consecutive days followed by a 2-day rest period)
  • Treatment will be repeated every 28 days
  • Imaging studies will be performed at baseline, at the end of treatment on cycle 1 (day 9 or 10), at the end of treatment on cycle 2 (day 12 or 13), and then every two cycles

Why is this trial important?

Hypoxia is a state of oxygen deficiency that can develop in tumors when they outgrow their blood supply. When this condition develops, tumors must adapt to the new hypoxic environment in order to survive and keep growing. A protein called hypoxia inducible factor-1a (HIF-1a) helps tumor cells (and normal cells) adapt to hypoxic conditions by activating genes needed for cell survival, resistance to apoptosis (programmed cell death), and the growth of new blood vessels (angiogenesis). Cancer cells may also produce HIF-1a as a result of genetic changes not related to hypoxia. Many solid tumors overproduce HIF-1a, and high levels of this protein have been associated with tumor aggressiveness and resistance to treatment.

The FDA-approved chemotherapy drug topotecan is one of only a few agents that have shown the ability to inhibit HIF-1a in laboratory studies. Animal studies conducted by NCI researchers suggest that giving topotecan at lower doses over a longer period of time can reduce the level of HIF-1a in tumors and inhibit angiogenesis. HIF-1a is believed to give tumors a selective growth advantage. The investigators are hoping to exploit a novel characteristic of an FDA-approved drug to take away this selective advantage and cause tumors to stop growing.

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