Hodgkin's DiseasePhase 2NCT00587873
Sequential Administration of Oral 6-Thioguanine (6-TG) After Methotrexate (MTX) in Patients With Relapsed Hodgkin's Disease (Phase II)
A Phase 2 study testing Methotrexate, Leucovorin calcium and 6-Thioguanine in people with Hodgkin's Disease, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hodgkin's Disease
- What is being tested?
- Methotrexate, Leucovorin calcium and 6-Thioguanine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1994to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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).
- Conditions
- Hodgkin's Disease
- Being tested
- Methotrexate, Leucovorin calcium, 6-Thioguanine
- Keywords
- Relapsed, Hodgkin's Disease, Methotrexate, 6-Thioguanine, 94-030
- Medical subject headings
- Hodgkin Disease, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called MTX
MTX 6mg/m2 given IV bolus, followed by 24mg/m2 given in 24hrs continuous infusion
5 mg orally at 12 hours after the end of MTX infusion then every 12 hrs for a total of 3 doses.
6-ThioguanineDrug
Also called 6-TG
6-TG 300 mg/m2 PO as a single oral dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MTX, 6-TG, and Leucovorin combination Receives: Drug: Methotrexate; Drug: Leucovorin calcium; Drug: 6-Thioguanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Conclusion of the study
Secondary outcomes (1)
Define Toxicity of this sequential drug combination.
Measured: Conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startMar 1994
- Primary completionDec 2003
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's DiseaseStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Tanya Trippett, MD, Principal investigator, Memorial Sloan-Kettering Cancer Center/94-030
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587873
- Sponsor's protocol ID
- 94-030
- Status last verified
- Jun 2009
- First submitted
- 26 Dec 2007
- Last updated
- 12 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Administration of Oral 6-Thioguanine (6-TG) After Methotrexate (MTX) in Patients With Relapsed Hodgkin's Disease (Phase II)
- ClinicalTrials.gov ID
- NCT00587873
- Acronym / sponsor ID
- 94-030
- Conditions
- Hodgkin's Disease
- Keywords
- Relapsed, Hodgkin's Disease, Methotrexate, 6-Thioguanine, 94-030
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Mar 1994
- Primary completion
- Dec 2003 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 8 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Methotrexate, Drug: Leucovorin calcium, Drug: 6-ThioguanineMTX, 6-TG, and Leucovorin combination |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateAlso: MTXMTX 6mg/m2 given IV bolus, followed by 24mg/m2 given in 24hrs continuous infusion | Drug | 1 |
| Leucovorin calcium5 mg orally at 12 hours after the end of MTX infusion then every 12 hrs for a total of 3 doses. | Drug | 1 |
| 6-ThioguanineAlso: 6-TG6-TG 300 mg/m2 PO as a single oral dose | Drug | 1 |
Primary outcome
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).
Time frame: Conclusion of the study
1 secondary outcome
Define Toxicity of this sequential drug combination.
Time frame: Conclusion of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2009.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya Trippett, MD principal investigator
Memorial Sloan-Kettering Cancer Center/94-030
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methotrexate, Leucovorin calcium and 6-Thioguanine in people with Hodgkin's Disease, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Conclusion of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2009.