Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies
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Purpose
The goal of this clinical research study is to learn if treatment with the drug liposomal vincristine can shrink or slow the growth of the patient's cancer. The safety of this drug will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Soft Tissue Sarcoma Lymphoma Leukemia Wilms' Tumor Osteosarcoma |
Drug: Liposomal Vincristine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies |
- Number of Patients with Response [ Time Frame: 3 Months post initiation of treatment ] [ Designated as safety issue: No ]Response defined as Complete Response or Partial Response.
| Enrollment: | 29 |
| Study Start Date: | June 2000 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Liposomal Vincristine |
Drug: Liposomal Vincristine
Vincristine Sulfate Liposome Injection (VSLI) administered via a central venous catheter at 2.0 mg/m2 over 60 minutes every 14 days + 2 days
Other Name: Vincristine Sulfate Liposome
|
Detailed Description:
Before and during the treatment patients will have exams done. These may include blood tests, urine tests, bone marrow tests, tests of the central nervous system, x-rays, or MRI/CT test. These are needed to measure the patient's clinical condition and progress. A physical exam and blood tests (about 2 teaspoons) will be repeated at least one time weekly.
Since Liposomal Vincristine may prevent the body from making and/or keeping new blood cells, prior to treatment patients will also have a Human Immunodeficiency Virus (AIDS virus) test, a blood test to detect the presence of antibodies to the AIDS virus. A separate informed consent will be given to be signed, in order to obtain permission for this test. Female patients may also be required to have a urine pregnancy test before treatment may begin, as it is not known how the drug may affect the unborn child.
Patients will receive liposomal vincristine through a central venous catheter (a plastic tube usually inserted under the collar bone) over one hour, once every 14 days, + 2 days. Patient's will also be given the drug docusate by the day liposomal vincristine is started. This is done to try to prevent constipation as a side effect.
All patients who show a continued response or stable disease without major side effects may continue to receive liposomal vincristine for up to 24 months. Patients with solid tumors and lymphoma will have X-rays performed every 8 weeks to follow the progression of their tumor. Patients with leukemia will have a bone marrow aspirate and biopsy done after the first and second months of treatment, and then every 8 weeks.
This is an investigational study. The FDA has authorized the use of the study drug in research. Up to 60 patients will take part in this study. Up to 30 patients will be enrolled at UTMDACC.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with relapsed malignancies in the following strata: (As of 09/01/02, the soft tissue sarcoma strata will remain open for new patient accrual. Strata listed in b, c, d, e will be closed to entry).
- soft tissue sarcoma
- bone sarcoma(CLOSED TO ENTRY AS OF 09/01/02)
- Wilms tumor(CLOSED TO ENTRY AS OF 09/01/02)
- lymphoma(CLOSED TO ENTRY AS OF 09/01/02)
- leukemia(CLOSED TO ENTRY AS OF 09/01/02)
- Performance status: Zubrod less than 3. Patients with long standing limited mobility requiring the use of a wheelchair will be considered ambulatory for the purpose of this protocol.
- Bidimensionally measurable disease radiologically.
- No anti-cancer treatment within the past 3 weeks.
- ANC greater than or equal to 500; platelets greater than or equal to 50,000; bilirubin less than or equal to 1.5 mg/dl; SGPT less than or equal to 4 x upper normal limit; creatinine less than or equal to 2 x normal. Patients with bone marrow infiltrative disease may be entered irrespective of ANC or platelets.
- Patients may be enrolled after BMT or PSCT if they meet all the above eligibility criteria.
Exclusion criteria:
- HIV positive.
- Serious intercurrent illness, active infections, or second cancer except basal cell carcinoma of the skin or cervical carcinoma in situ.
- Eligible for treatment of a higher priority.
- Pregnancy.
- Grade 3 or 4 sensory or motor dysfunction due to prior vinca alkaloids.
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Cynthia E. Herzog, MD, BA | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00038207 History of Changes |
| Other Study ID Numbers: | P99-401 |
| Study First Received: | May 29, 2002 |
| Last Updated: | July 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
soft tissue sarcoma Bone sarcomas |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Wilms Tumor Osteosarcoma Sarcoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms, Complex and Mixed Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Neoplastic Syndromes, Hereditary Kidney Diseases Urologic Diseases Genetic Diseases, Inborn Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Vincristine Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013