Clinical trial NCT00364676: Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Hodgkins Disease
Non-Hodgkins Lymphoma
Keywords: Vinorelbine
solid tumors
Hodgkins
Non hodgkins
Lymphoma
Advanced solid tumors
Lead sponsor: Spectrum Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2006-08-16
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 disease.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the safety and tolerability of VLI.
timeFrame: 21 Days
Secondary outcomes:
measure: To determine the maximum tolerated dose (MTD)
timeFrame: 21 Days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Cancer Therapy and Research Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics
state: Texas
city: Montreal
country: Canada
facility: McGill Centre for Translational Research in Cancer-Jewish General Hospital Clinical Research Unit
state: Quebec
Study officials:
affiliation: Cancer Therapy and Research Center, Texas
name: John Sarantopoulos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill Centre for Translational Research in Cancer-Jewish General Hospital Clinical Research Unit
name: Gerald Batist, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: South Texas Accelerated Research Therapeutics
name: Anthony W. Tolcher, MD
role: PRINCIPAL_INVESTIGATOR
References: