Irinotecan, Vincristine, and Dexamethasone In Children With Relapsed And/Or Refractory Hematologic Malignancies

NCT00718757 | Completed Phase 1 DMC

• 1 other identifier: VIDML
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Non-Hodgkins Lymphoma; Hodgkin's Disease; Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• 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

  Maximum Tolerated Dose (MTD)

Study Arms (1)

1

EXPERIMENTAL

Drug: Dexamethasone; Drug: Irinotecan; Drug: Vincristine

Interventions

Dexamethasone DRUG

5 doses given on Days 6-10

1

Irinotecan DRUG

20 mg/m2/day IV, 10 doses given on Days 1-5, 8-12

1

Vincristine DRUG

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

1

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (2)

Rady's Children Hospital San Diego

San Diego, California, 92123, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Dexamethasone; Irinotecan; Vincristine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Camptothecin; Alkaloids; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• John T Sandlund, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2008
• First Posted: July 21, 2008
• Study Start: January 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: August 28, 2013

Record last verified: 2013-08

Locations

US (2)