Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease
This study is ongoing, but not recruiting participants.
Sponsor:
Talon Therapeutics, Inc
Information provided by (Responsible Party):
Talon Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00364676
First received: August 14, 2006
Last updated: September 25, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tumors Hodgkins Disease Non-Hodgkins Lymphoma |
Drug: VLI |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Talon Therapeutics, Inc:
Primary Outcome Measures:
- Evaluate the safety and tolerability of VLI. [ Time Frame: 21 Days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine the maximum tolerated dose (MTD) [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 67 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Patients are dosed on Day 1 and Day 8 of a 21-day cycle.
|
Drug: VLI
Patients are dosed on Day 1 and Day 8 of a 21-day cycle.
|
|
Experimental: 2
Patients are dosed on Day 1 of a 21-day cycle.
|
Drug: VLI
Patients are dosed on Day 1 of a 21-day cycle.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364676
Locations
| United States, Texas | |
| Cancer Therapy and Research Center | |
| San Antonio, Texas, United States, 78229 | |
| South Texas Accelerated Research Therapeutics | |
| San Antonio, Texas, United States, 78229 | |
| Canada, Quebec | |
| McGill Centre for Translational Research in Cancer-Jewish General Hospital Clinical Research Unit | |
| Montreal, Quebec, Canada, H3T 1E2 | |
Sponsors and Collaborators
Talon Therapeutics, Inc
Investigators
| Principal Investigator: | John Sarantopoulos, MD | Cancer Therapy and Research Center, Texas |
| Principal Investigator: | Gerald Batist, MD | McGill Centre for Translational Research in Cancer-Jewish General Hospital Clinical Research Unit |
| Principal Investigator: | Anthony W. Tolcher, MD | South Texas Accelerated Research Therapeutics |
More Information
No publications provided
| Responsible Party: | Talon Therapeutics, Inc |
| ClinicalTrials.gov Identifier: | NCT00364676 History of Changes |
| Other Study ID Numbers: | HBS501 |
| Study First Received: | August 14, 2006 |
| Last Updated: | September 25, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Talon Therapeutics, Inc:
|
Vinorelbine solid tumors Hodgkins |
Non hodgkins Lymphoma Advanced solid tumors |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Vinorelbine Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013