Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease
Study Details
Study Description
Brief Summary
This Phase 1 study will determine the safety, tolerability, and pharmacokinetics of vinorelbine liposomes injection (VLI) in patients with advanced solid tumors, non-Hodgkin's lymphoma, or Hodgkin's disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
The objectives of this study are:
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To assess the safety and tolerability of treatment with VLI.
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To determine the maximum tolerated dose (MTD) of VLI.
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To characterize the pharmacokinetic (PK) profile of VLI.
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To explore preliminary tumor response of VLI.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Patients are dosed on Day 1 and Day 8 of a 21-day cycle. |
Drug: VLI
Patients are dosed on Day 1 and Day 8 of a 21-day cycle.
|
| Experimental: 2 Patients are dosed on Day 1 of a 21-day cycle. |
Drug: VLI
Patients are dosed on Day 1 of a 21-day cycle.
|
Outcome Measures
Primary Outcome Measures
- Evaluate the safety and tolerability of VLI. [21 Days]
Secondary Outcome Measures
- To determine the maximum tolerated dose (MTD) [21 Days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed solid tumor refractory to standard therapy or for which no standard therapy is known to exist, or relapsed and/or refractory non-Hodgkin's lymphoma or Hodgkin's disease
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Adequate hematologic, hepatic and renal functions as defined by laboratory tests.
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At least 18 years of age.
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Have a life expectancy of at least 12 weeks.
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Patients must give written informed consent.
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ECOG or Zubrod performance status of 0, 1, or 2.
Exclusion Criteria:
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Primary tumors of central nervous system (CNS). Symptomatic brain metastases (unless patient is stable without requirement of steroids and/or antiseizure medications for at least 3 months) or leptomeningeal tumor involvement.
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Prior chemotherapy or radiotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas and mitomycin C).
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Planned concurrent systemic therapy and/or radiotherapy drug study treatment.
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Use of investigational drugs, biologics or devices within 28 days prior to study treatment or planned use during the course of the study.
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Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment.
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Prophylactic hematologic growth factors administered less than or equal to 2 weeks prior to start of therapy with VLI (excluding darbepoetin alfa, epoetin alfa).
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Female patients who are pregnant or lactating.
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Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cancer Therapy and Research Center | San Antonio | Texas | United States | 78229 |
| 2 | South Texas Accelerated Research Therapeutics | San Antonio | Texas | United States | 78229 |
| 3 | McGill Centre for Translational Research in Cancer-Jewish General Hospital Clinical Research Unit | Montreal | Quebec | Canada | H3T 1E2 |
Sponsors and Collaborators
- Spectrum Pharmaceuticals, Inc
Investigators
- Principal Investigator: John Sarantopoulos, MD, Cancer Therapy and Research Center, Texas
- Principal Investigator: Gerald Batist, MD, McGill Centre for Translational Research in Cancer-Jewish General Hospital Clinical Research Unit
- Principal Investigator: Anthony W. Tolcher, MD, South Texas Accelerated Research Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HBS501