Solid Tumor (Adult)
Phase I Study of SNX-5422 Mesylate in Adults With Refractory Solid Tumor Malignancies and Lymphomas
NCI-08-C-0091
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Investigator(s): |
Giuseppe Giaccone, M.D., Ph.D. Principal Investigator Phone: 301-496-4916 Fax: 301-402-0172 giacconeg@mail.nih.gov
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Janelle Bingham, R.N. Referral Coordinator Phone: 301-435-2715 jbingham@mail.nih.gov
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Sonja Crandon, R.N. Research Nurse Phone: 301-594-4325 Fax: 301-480-7281 crandons@mail.nih.gov
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Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-480-0919 ottenl@mail.nih.gov
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Primary Eligibility:
- Histologically documented diagnosis of one of the following:
- Solid tumor
- Lymphoid malignancy (i.e., lymphoma or chronic lymphocytic leukemia)
- Aggressive non-Hodgkin’s lymphoma (NHL) must have progressed after treatment with two standard therapies
- Indolent NHL must be considered refractory
- Refractory to standard therapy OR no acceptable standard treatment options
- Measurable or evaluable disease
- No symptomatic brain metastasis
- Patients with treated brain metastasis that has remained stable ≥ 3 months without steroids allowed
- Recovered from all prior therapy
- No prior gastric bypass surgery
- No other concurrent investigational agents
- No other concurrent antineoplastic therapies except androgen deprivation therapy (i.e., gonadotropin-releasing hormone) in patients with prostate cancer
- Concurrent bisphosphonates for cancer allowed
- ECOG performance status (PS) 0–2 (Karnofsky PS 60–100%)
- ANC ≥ 1,500 /μL
- Platelet count ≥ 100,000 /μL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (≤ 2.5 mg/dL in patients with Gilbert syndrome)
- AST and ALT ≤ 2.5 x ULN
- Creatinine < 1.5 x ULN OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing; fertile patients must use effective contraception during and for 2 months after completion of study therapy
- No medical condition that would preclude study participation
- No chronic diarrhea
- No gastrointestinal diseases that could affect drug absorption
- No gastrointestinal diseases that could alter the assessment of safety, including any of the following:
- Irritable bowel syndrome
- Ulcerative colitis
- Crohn’s disease
- Hemorrhagic coloproctitis
- HIV negative
Treatment Plan:
- Patients receive oral Hsp90 inhibitor SNX-5422 mesylate twice weekly in weeks 1–4
- Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
- Patients undergo blood and urine sample collection for pharmacokinetic and pharmacodynamic analysis in course 1
- After completion of study therapy, patients are followed periodically
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.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 8/28/08
Updated: 11/14/08