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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

Phase 1
18 Years
Open (Enrolling)
Tumors, Hodgkins Disease, Non-Hodgkins Lymphoma

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Trial Information

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

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:

1. 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

2. Adequate hematologic, hepatic and renal functions as defined by laboratory tests.

3. At least 18 years of age.

4. Have a life expectancy of at least 12 weeks.

5. Patients must give written informed consent.

6. ECOG or Zubrod performance status of 0, 1, or 2.

Exclusion Criteria:

1. 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.

2. Prior chemotherapy or radiotherapy within 4 weeks prior to study entry (6 weeks for
nitrosoureas and mitomycin C).

3. Planned concurrent systemic therapy and/or radiotherapy drug study treatment.

4. Use of investigational drugs, biologics or devices within 28 days prior to study
treatment or planned use during the course of the study.

5. Active infection or any serious underlying medical condition, which would impair the
ability of the patient to receive protocol treatment.

6. Prophylactic hematologic growth factors administered less than or equal to 2 weeks
prior to start of therapy with VLI (excluding darbepoetin alfa, epoetin alfa).

7. Female patients who are pregnant or lactating.

8. Dementia or significantly altered mental status that would prohibit the understanding
and giving of informed consent.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the safety and tolerability of VLI.

Outcome Time Frame:

21 Days

Safety Issue:


Principal Investigator

John Sarantopoulos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Therapy and Research Center, Texas


United States: Food and Drug Administration

Study ID:




Start Date:

July 2006

Completion Date:

December 2012

Related Keywords:

  • Tumors
  • Hodgkins Disease
  • Non-Hodgkins Lymphoma
  • Vinorelbine
  • solid tumors
  • Hodgkins
  • Non hodgkins
  • Lymphoma
  • Advanced solid tumors
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin



Cancer Therapy and Research Center San Antonio, Texas  78229
South Texas Accelerated Research Therapeutics San Antonio, Texas  78229