Hodgkins Disease, Non-Hodgkins Lymphoma, Tumors
Conditions
Keywords
Vinorelbine, solid tumors, Hodgkins, Non hodgkins, Lymphoma, Advanced solid tumors
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.
Interventions
DRUGVLI
Patients are dosed on Day 1 and Day 8 of a 21-day cycle.
Sponsors
Spectrum Pharmaceuticals, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the safety and tolerability of VLI. | 21 Days |
Secondary
| Measure | Time frame |
|---|---|
| To determine the maximum tolerated dose (MTD) | 21 Days |
Countries
Canada, United States
Outcome results
None listed