Systemic SclerosisPhase 2NCT00016458
Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis
A Phase 2 study testing anti-thymocyte globulin and cyclophosphamide in people with Systemic Sclerosis, run by Fred Hutchinson Cancer Center at 3 sites in United States.
Trial summary
OBJECTIVES: I. Determine the toxicity of cyclophosphamide and rabbit anti-thymocyte globulin in patients with diffuse systemic sclerosis. II. Determine the efficacy of this regimen in terms of controlling disease in these patients. Read more about this study
- Who is it for?
- Ages Up to 64 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- anti-thymocyte globulin and cyclophosphamide
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2000to not given
- 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 Up to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Diagnosis of diffuse systemic sclerosis
Progressive disease Skin score at least 16 Interstitial or pulmonary vasculitis (FVC or DLCO no greater than 70% predicted) with evidence of alveolitis by bronchoalveolar lavage (BAL) Proteinuria (more than 500 mg/24 hours) Rapid deterioration in pulmonary function (at least 15% decrease in FVC or DLCO within the past 6 months) or new evidence of alveolitis by CT scan changes or BAL
No acute renal failure secondary to systemic sclerosis crisis
DLCO greater than 20% predicted
Ineligible for or refused autologous or allogeneic peripheral blood stem cell or bone marrow transplantation
--Prior/Concurrent Therapy--
Endocrine therapy: Concurrent prednisone allowed if prior chronic use
Other: At least 4 days since prior immunosuppressive therapy
--Patient Characteristics--
Performance status: Karnofsky 50-100%
Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin less than 2.5 times upper limit of normal (ULN) SGOT less than 2.5 times ULN
Renal: See Disease Characteristics Creatinine clearance at least 35 mL/min No requirement for renal dialysis
Cardiovascular: Ejection fraction greater than 45% No myocardial infarction within the past 12 months No unstable angina No uncontrolled cardiac arrhythmias No evidence of congestive heart failure
Pulmonary: See Disease Characteristics
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No active uncontrolled infection
- No hypersensitivity to rabbit proteins
- No prior hemorrhagic cystitis requiring transfusion
- No concurrent active hemorrhagic cystitis by cystoscopy (if prior history)
- No concurrent malignancy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado Cancer Center
Denver, Colorado, 80262
Duke University Medical Center
Durham, North Carolina, 27710
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
OBJECTIVES: I. Determine the toxicity of cyclophosphamide and rabbit anti-thymocyte globulin in patients with diffuse systemic sclerosis.
II. Determine the efficacy of this regimen in terms of controlling disease in these patients.
Read the detailed description
PROTOCOL OUTLINE: Patients receive cyclophosphamide IV over 1-2 hours on day 1 and rabbit anti-thymocyte globulin IV over 6-8 hours on days 2-5.
Patients are followed on days 60-85 and then every 3 months for 1 year.
- Conditions
- Systemic Sclerosis
- Being tested
- anti-thymocyte globulin, cyclophosphamide
- Keywords
- arthritis & connective tissue diseases, rare disease, systemic sclerosis
- Medical subject headings
- Scleroderma, Systemic, Arthritis, Connective Tissue Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-thymocyte globulinDrug
cyclophosphamideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2001 (estimated)
- Study startJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson 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
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Leona Holmberg, Study chair, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016458
- Sponsor's protocol ID
- 199/15818
- Other IDs
- FHCRC-1473.00
- Status last verified
- Sep 2008
- First submitted
- 6 May 2001
- Last updated
- 3 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT00016458
- Acronym / sponsor ID
- 199/15818
- Conditions
- Systemic Sclerosis
- Keywords
- arthritis & connective tissue diseases, rare disease, systemic sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- Jun 2000
- First posted
- 7 May 2001 (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.
OBJECTIVES: I. Determine the toxicity of cyclophosphamide and rabbit anti-thymocyte globulin in patients with diffuse systemic sclerosis.
II. Determine the efficacy of this regimen in terms of controlling disease in these patients.
Detailed description
PROTOCOL OUTLINE: Patients receive cyclophosphamide IV over 1-2 hours on day 1 and rabbit anti-thymocyte globulin IV over 6-8 hours on days 2-5.
Patients are followed on days 60-85 and then every 3 months for 1 year.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- Up to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| anti-thymocyte globulin | Drug | – |
| cyclophosphamide | Drug | – |
Primary outcome
Not reported in the source record.
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 3 Sep 2008.
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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.
Leona Holmberg study chair
Fred Hutchinson Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anti-thymocyte globulin and cyclophosphamide in people with Systemic Sclerosis, run by Fred Hutchinson Cancer Center at 3 sites 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?
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 3 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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 3 Sep 2008.