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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 1 Study of Vinorelbine Liposomes Injection (VLI) for Treatment in Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease

Conditions
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Tumors, Hodgkins Disease, Non-Hodgkins Lymphoma

Intervention / Treatment
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* Drug: VLI
* Drug: VLI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients are dosed on Day 1 and Day 8 of a 21-day cycle. | Drug: VLI<br>* Patients are dosed on Day 1 and Day 8 of a 21-day cycle.<br>|
| Experimental: 2<br>Patients are dosed on Day 1 of a 21-day cycle. | Drug: VLI<br>* Patients are dosed on Day 1 of a 21-day cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and tolerability of VLI. |  | 21 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the maximum tolerated dose (MTD) |  | 21 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vinorelbine, solid tumors, Hodgkins, Non hodgkins, Lymphoma, Advanced solid tumors