Irinotecan, Vincristine, and Dexamethasone In Children With Relapsed And/Or Refractory Hematologic Malignancies
This study is ongoing, but not recruiting participants.
Sponsor:
St. Jude Children's Research Hospital
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00718757
First received: July 17, 2008
Last updated: July 24, 2012
Last verified: July 2012
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Purpose
The purpose of this study is to estimate the maximum tolerated dose of dexamethasone given for 5 consecutive days when combined with fixed doses of irinotecan (given IV, qd x 5, 2 days off, qd x 5) and vincristine (given IV, 2 doses total on days 1 and 8 of schedule) in children with relapsed or refractory hematologic malignancies. In addition we will also study the pharmacokinetics of irinotecan when given without and then with dexamethasone in each patient, evaluate the relationship between irinotecan pharmacokinetic parameters and toxicity and describe any antitumor effects.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkins Lymphoma Hodgkin's Disease Acute Lymphoblastic Leukemia |
Drug: Dexamethasone Drug: Irinotecan Drug: Vincristine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Trial Using Irinotecan, Vincristine, and Dexamethasone In Children With Relapsed And/Or Refractory Hematologic Malignancies |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Vincristine sulfate
Dexamethasone sodium phosphate
Irinotecan
Irinotecan hydrochloride
U.S. FDA Resources
Further study details as provided by St. Jude Children's Research Hospital:
Primary Outcome Measures:
- Estimate the maximum tolerated dose of dexamethasone given for 5 consecutive days when combined with fixed doses of irinotecan and vincristine in children with relapsed hematologic malignancies [ Time Frame: Maximum Tolerated Dose (MTD) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 18 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | September 2013 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Dexamethasone
5 doses given on Days 6-10
Drug: Irinotecan
20 mg/m2/day IV, 10 doses given on Days 1-5, 8-12
Drug: Vincristine
1.5 mg/m2/day IV (max 2 mg), 2 doses given on Days 1,8 * Patients < 1 year of age or < 10kg in weight: Vincristine 0.05 mg/kg |
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age < or equal to 21 years at time of study entry
- Pathological diagnosis of a recurrent or refractory Non-Hodgkin's lymphoma, Hodgkin's disease, or acute lymphoblastic leukemia
- ECOG performance status < or equal to 2 (or Lansky play-performance scale > or equal to 50% for children <10 years of age).
- Has not received chemotherapy in previous 2 weeks. In the case of rapidly progressing disease, this criterion may be waived by consulting with the Principal Investigator, provided the patient has recovered from the acute effects of prior therapy.
- Hemoglobin >8 g/dl, absolute neutrophil count >1000 /mm3 (without growth factor support), and platelet count >50,000/mm3 (without transfusion support) unless bone marrow is involved with tumor or leukemia
- Adequate liver function (bilirubin < 1.5 x normal for age, AST and ALT < 3 x normal for age)
- Adequate renal function (serum creatinine <3 x normal for age)
- No active graft-versus-host disease (GVHD) or ongoing treatment for GVHD
Exclusion Criteria:
- Currently receiving other cytotoxic or investigational drugs
- Pregnant or lactating females are not eligible. Pregnancy tests must be obtained in females who are post-menarchal.
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, azole antifungals, aprepitant, or St. John's Wort is not allowed.
- Evidence of active infection at the time of protocol entry
- History of allergy to any of the study medications
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718757
Locations
| United States, California | |
| Rady's Children Hospital San Diego | |
| San Diego, California, United States, 92123 | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
| Principal Investigator: | John T Sandlund, MD | St. Jude Children's Research Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00718757 History of Changes |
| Other Study ID Numbers: | VIDML |
| Study First Received: | July 17, 2008 |
| Last Updated: | July 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Hodgkin Disease Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma Lymphoma, Non-Hodgkin Hematologic Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms by Site Hematologic Diseases |
Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Irinotecan Vincristine BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 23, 2013