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

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) profile of VLI.
• To explore preliminary tumor response of VLI.

Inclusion criteria

• 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 criteria

• 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.