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Investigator(s):
Ann W. Gramza, M.D. Principal Investigator Phone: 301-827-4989 gramzaaw@mail.nih.gov
Referral Contact(s):
Erinn M. Hopkins Clinical Research Coordinator Phone: 301-496-6457 erinn.hopkins@nih.gov	Jean Ward, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-827-4988 Fax: 301-480-2481 wardjl@mail.nih.gov	Krisana Gesuwan, C.R.N.P. Research Nurse Specialist Phone: 301-402-4395 Fax: 301-451-6933 gesuwank2@mail.nih.gov

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Key Eligibility Criteria:

• Diagnosis of:
• Phase I: Recurrent, metastatic, or primary unresectable solid tumor that does not have curative standard treatment
• Phase II: Recurrent, metastatic, or primary unresectable anaplastic thyroid cancer (ATC), including ATC as part of a thyroid carcinoma of another histologic subtype
• ECOG 0–1
• No untreated brain metastases (or local treatment of brain metastases within the last 3 months)
• No evidence of severe or uncontrolled systemic disease or any concurrent condition that in the investigator's opinion makes it undesirable for the patient to participate in the trial or that would jeopardize compliance with the protocol
• Phase II only
• No previous treatment with cisplatin
• Measurable disease by RECIST criteria

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Study Outline:

This is a Phase I dose-escalation study followed by a randomized Phase II study.

• Phase I:
• Inpatient study treatment consisting of an IV infusion (through a vein) of cisplatin and crolibulin on the first day and then an IV infusion of crolibulin alone on the second and third days
• Study treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity
• Phase II
:
• Patients are randomized to one of two study treatment arms
• Arm I
:
• Inpatient study treatment consisting of an IV infusion of cisplatin and crolibulin on the first day and then an IV infusion of crolibulin alone on the second and third days
• Study treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity
• Arm II
:
• Inpatient study treatment consisting of an IV infusion of cisplatin
• Study treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity
• Patients randomized to cisplatin alone will have the opportunity to cross over to the crolibulin arm in the event of tumor progression

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 12/14/12
Updated: 11/12/12