Solid Tumor
A Phase I, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Dimethane Sulfonate (DMS612, NSC 281612) in Advanced Malignancies
NCI-09-C-0111
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Investigator(s): |
Susan Bates, M.D.
Principal Investigator
Phone: 301-402-1357
sebates@helix.nih.gov
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Debbie Draper, R.N., B.S.N.
Research Nurse
Phone: 301-435-8525
draperde@mail.nih.gov
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Primary Eligibility:
- Histologically confirmed solid tumors or lymphoma
- Metastatic or unresectable disease
- Standard curative or palliative measures do not exist OR are no longer effective
- No history of CNS metastasis unless control has been achieved with either radiotherapy or surgery
- Recovered from prior therapy
- No prior radiotherapy to > 25% of bone marrow
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent cytochrome p450-inducing anticonvulsants
- No concurrent cytochrome p450 isoenzyme CYP3A4 inhibitors or inducers
- Concurrent luteinizing hormone-releasing hormone agonist therapy for prostate cancer allowed
- Concurrent IV bisphosphonates for bone metastases or hypercalcemia allowed
- ECOG performance status (PS) 0–2 (Karnofsky PS 60–100%)
- Leukocyte count ≥ 3,000/mm3
- Absolute neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Total bilirubin normal
- AST and ALT ≤ 1.5 x upper limit of normal
- Creatinine normal OR creatinine clearance > 50 mL/min
- Not pregnant or nursing; fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
- No medical condition that would preclude study participation
- No alcoholism
Study Outline:
- Patients receive methylene dimethane sulfonate IV over 10 minutes on Days 1, 8, and 15
- Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
- Patients undergo periodic blood sample collection
- After completion of study treatment, patients are followed for 30 days
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:
Updated: 6/24/09
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