Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease

Completed · Phase 1

Conditions studied: Tumors, Hodgkins Disease, Non-Hodgkins Lymphoma

In brief

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.

Key facts

Study ID

NCT00364676

Run by

Spectrum Pharmaceuticals, Inc

People needed

67

Starts

2006-07-01

Expected to finish

2015-08-01

Last updated by the study team

2015-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cancer Therapy and Research Center — San Antonio, Texas, United States
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States
• McGill Centre for Translational Research in Cancer-Jewish General Hospital Clinical Research Unit — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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