CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 81 enrolled
Drug / intervention
Adriamycin® +9 moredrug
Likely dose
Stanford V chemotherapy: Adriamycin IV day 1 of weeks 1, 3, 5, 7, 9, 11; Vinblastine IV day 1 of weeks 1, 3, 5, 7, 9, 11; Nitrogen Mustard (or Cyclophosphamide) IV day 1 of weeks 1, 5, 9; Vincristine IV day 1 of weeks 2, 4, 6, 8, 10, 12; Bleomycin IV day 1 of weeks 2, 4, 6, 8, 10, 12; Etoposide IV days 1-2 of weeks 1-10; Prednisone PO every other day weeks 1-12; followed by radiotherapyAI-extracted
Key inclusion· 3
  • Age ≤21 years
  • Confirmed diagnosis of previously untreated Hodgkin lymphoma
  • Ann Arbor stage IB, IIIA, or IA/IIA with extranodal extension, multiple nodal involvement (≥3 sites), or bulky mediastinal adenopathy
Key exclusion· 3
  • Favorable risk features (excludes low-risk disease)
  • Unfavorable risk features (excludes high-risk disease)
  • Prior therapy for Hodgkin lymphoma

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00352027
NCT00352027Phase 2Completed

Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma

St. Jude Children's Research Hospital·interventional·Posted Jul 14, 2006·Updated Sep 22, 2023

In Brief

A Phase 2 clinical trial evaluating Adriamycin®, Vinblastine, and 8 other interventions for Hodgkin's Lymphoma. Completed, enrolled 81 participants across 6 sites.

Detailed Summary

The main purpose of this protocol is to estimate the percentage of patients with intermediate risk Hodgkin lymphoma who will survive free of disease (Event-free survival) for three years after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field radiation therapy. The hypothesis being studied is that this treatment will result in more than 80% of patients being alive and free of disease three years after starting treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 14, 2006
Enrollment StartJul 20, 2006
Primary CompletionMay 1, 2015
Study CompletionNov 15, 2022
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 20.0 years ago

Interventions

Adriamycin®drug

Given IV on Day 1 of weeks 1, 3, 5, 7, 9 and 11.

Vinblastinedrug

Given IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11.

Nitrogen Mustarddrug

Given IV, Day 1 of weeks 1, 5 and 9. Cyclophosphamide may be substituted if nitrogen mustard is unavailable.

Cyclophosphamidedrug

May be substituted if nitrogen mustard is unavailable. Given on Day 1 of weeks 1, 5 and 9.

Vincristinedrug

Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.

Bleomycindrug

Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.

Etoposidedrug

Given IV on Days 1 and 2 of weeks 1-10.

Prednisonedrug

Given PO every other day of weeks 1-12.

G-CSFbiological

Given subcutaneously days 3-13, 16-26, 29-39, 42-52, 55-65, and 68-78 (as clinically indicated).

Radiotherapyprocedure

Participants receive radiotherapy after completion of 12 weeks of Stanford V chemotherapy.