Status:
COMPLETED
Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Conditions:
Tumors
Hodgkins Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 d...
Detailed Description
The objectives of this study are: * To assess the safety and tolerability of treatment with VLI. * To determine the maximum tolerated dose (MTD) of VLI. * To characterize the pharmacokinetic (PK) pro...
Eligibility Criteria
Inclusion
- 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
- Adequate hematologic, hepatic and renal functions as defined by laboratory tests.
- At least 18 years of age.
- Have a life expectancy of at least 12 weeks.
- Patients must give written informed consent.
- ECOG or Zubrod performance status of 0, 1, or 2.
Exclusion
- 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.
- Prior chemotherapy or radiotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas and mitomycin C).
- Planned concurrent systemic therapy and/or radiotherapy drug study treatment.
- Use of investigational drugs, biologics or devices within 28 days prior to study treatment or planned use during the course of the study.
- Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment.
- Prophylactic hematologic growth factors administered less than or equal to 2 weeks prior to start of therapy with VLI (excluding darbepoetin alfa, epoetin alfa).
- Female patients who are pregnant or lactating.
- Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00364676
Start Date
July 1 2006
End Date
August 1 2015
Last Update
September 22 2015
Active Locations (3)
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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