NCT00587873

Brief Summary

The objective of this study is to determine the incidence of complete and partial response and the duration of response in patients with recurrent or resistant Hodgkin's disease (HD) treated with sequential administration of oral 6-Thioguanin (6-TG) after IV Methotrexate (MTX).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 1994

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1994

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 8, 2008

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 12, 2009

Status Verified

June 1, 2009

Enrollment Period

9.8 years

First QC Date

December 26, 2007

Last Update Submit

June 10, 2009

Conditions

Hodgkin's Disease

Keywords

RelapsedHodgkin's DiseaseMethotrexate6-Thioguanine94-030

Outcome Measures

Primary Outcomes (1)

  • To determine the incidence of complete and partial response and the duration of response in patients with recurrent or resistant Hodgkin's Disease (HD) treated with sequential administration of oral 6-Thioguanine (6-TG) after IV Methotrexate (MTX).

    Conclusion of the study

Secondary Outcomes (1)

  • Define Toxicity of this sequential drug combination.

    Conclusion of study

Study Arms (1)

1

EXPERIMENTAL

MTX, 6-TG, and Leucovorin combination

Drug: MethotrexateDrug: Leucovorin calciumDrug: 6-Thioguanine

Interventions

MethotrexateDRUG

MTX 6mg/m2 given IV bolus, followed by 24mg/m2 given in 24hrs continuous infusion

Also known as: MTX
1
Leucovorin calciumDRUG

5 mg orally at 12 hours after the end of MTX infusion then every 12 hrs for a total of 3 doses.

1
6-ThioguanineDRUG

6-TG 300 mg/m2 PO as a single oral dose

Also known as: 6-TG
1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologic proof of HD who are in relapse and have failed \> or = to 2 prior chemotherapy regimens.
  • Patients must have a life expectancy of at least 8 weeks.
  • All patients must have ECOG performance level rating of \< or = to 2.
  • Patients or their parents (guardian) must sign an informed consent indicating that they are aware of the investigational nature of the study.
  • Patients must have recovered from the toxic effects of prior therapy before entering this study or at least 2 weeks should have elapsed since the end of last course of CT.
  • Patients must have adequate liver function (bilirubin \< or = to 2.0 mg/dl, SGOT less than 1.5 times normal (unless it is due to disease), adequate renal function (creatinine \< or = to 1.5 mg/dl, creatinine clearance \> or = to 60 ml/min/1.73 m2).
  • Patients should have a granulocyte count \> or = to 500/gL and a platelet count \> or = to 100,000/uL (unless due to disease involvement of the bone marrow).
  • Male and female patients of child-bearing age should use effective methods of contraception, if sexually active.

You may not qualify if:

  • Patients with active infections or significant medical conditions other than their malignancy shall be excluded.
  • Patients with HD who had prior MTX or 6-TG should be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Hodgkin DiseaseRecurrence

Interventions

MethotrexateLeucovorinThioguanine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidCoenzymesEnzymes and CoenzymesPurines

Study Officials

  • Tanya Trippett, MD

    Memorial Sloan-Kettering Cancer Center/94-030

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 8, 2008

Study Start

March 1, 1994

Primary Completion

December 1, 2003

Study Completion

June 1, 2009

Last Updated

June 12, 2009

Record last verified: 2009-06

Locations

US(1)