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Hodgkin DiseasePhase 2NCT00388349

Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease

A Phase 2 study testing Gemcitabine, Vinorelbine and Carmustine in people with Hodgkin Disease and Hodgkin's Lymphoma, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase 2 study of gemcitabine + high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue for Hodgkin's Disease Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hodgkin Disease, Hodgkin's Lymphoma, Lymphoma
What is being tested?
Gemcitabine, Vinorelbine and Carmustine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
1 siteUnited States
Study dates
Sep 2001to Sep 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically-proven recurrent or refractory Hodgkin's Disease (Hodgkin's lymphoma) on the basis of excisional biopsy whenever possible.
  • Age < 70 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3.
  • Phase 1 study component only: 1 or more of the following adverse risk factors
  • Stage IV extranodal disease at relapse "B" symptoms
  • Failure to achieve minimal disease with most recent chemotherapy (single lymph nodes < 2 cm or >75% reduction in a bulky tumor mass and bone marrow involvement < 10%)
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  • Progression during induction or salvage therapy
  • Phase 2 study component only: No risk factor criteria
  • Computerized tomography (CT) scan of the chest, abdomen and pelvis, with assessment of response to last chemotherapy, within 4 weeks of registration. Gallium scan or positron emission tomography (PET) scan confirmation of disease within 4 weeks of registration is highly recommended
  • Bone marrow biopsy and cytogenetic analysis within 8 weeks of registration
  • Women of child-bearing potential and sexually active males expected to use an accepted and effective method of birth control
  • Pretreatment serum bilirubin < 2 x the institutional upper limit of normal (ULN) (within 28 days prior to registration)
  • Serum creatinine < 2 x the institutional ULN (within 28 days prior to registration)
  • Measured or estimated creatinine clearance > 60 cc/min by the following formula (within 28 days prior to registration):
  • Estimated Creatinine Clearance = (140 age) x WT(kg) x 0.85 (if female) x creatinine (mg/dL)
  • Electrocardiogram (ECG) demonstrating no significant abnormalities suggestive of active cardiac disease (within 42 days prior to registration)
  • Patients over age 50, who have received chest irradiation or a total of 300 mg/m2 of doxorubicin or with any history of cardiac disease must have a radionuclide ejection fraction (within 42 days prior to registration). If the ejection fraction is 40 to 50%, the patient will have a cardiology consult
  • Corrected diffusion capacity > 55%
  • Written informed consent in accordance with institutional and federal guidelines

Who cannot join

  • Positive HIV antibody test (must be conducted within 42 days of registration)
  • No chemotherapy other than corticosteroids should be administered within 2 weeks of the initiation of protocol therapy
  • Pregnant
  • Breast-feeding
  • Requiring therapy for:
  • Coronary artery disease
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  • Cardiomyopathy
  • Dysrhythmia, or
  • Congestive heart failure
  • Over age 50 and has received chest irradiation or a total of 300 mg/m^2 of doxorubicin
  • History of cardiac disease and the ejection fraction is < 40% (radionuclide ejection fraction must be within 42 days of registration)
  • Known allergy to etoposide
  • History of Grade 3 hemorrhagic cystitis with cyclophosphamide
  • History of grade 2 or greater sensory or motor peripheral neuropathy due to prior vinca alkaloid use
  • No prior malignancy (EXCEPTION: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; or other cancer for which the patients has been disease-free for 5 years). Patients with a prior diagnosis of non-Hodgkin's lymphoma are not eligible.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Official title: Gemcitabine and High-dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease

This is a phase 2 study of gemcitabine + high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue for Hodgkin's Disease

Read the detailed description

To assess the non-hematologic toxicity and determine the phase 2 dose of gemcitabine in combination with vinorelbine followed by carmustine, etoposide and cyclophosphamide and autologous hematopoietic stem cell transplantation [aka peripheral blood stem cell (PBSC)].

Medical subject headings
Hodgkin Disease, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

    Also called Gemzar

  • VinorelbineDrug

    Also called Navelbine

  • CarmustineDrug

    Also called BCNU

  • EtoposideDrug

    Also called Vepesid

  • CyclophosphamideDrug

    Also called Cytoxan, Neosar

  • Autologous HCTProcedure or surgery

    Also called Peripheral blood stem cell (PBSC) rescue

Study groups in NCT00388349
Study groupRoleWhat they receive
Gemcitabine + Autologous HCTExperimentalGemcitabine and high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue. Chemotherapy includes Gemcitabine + Vinorelbine + Carmustine + Etoposide + Cyclophosphamide.
Receives: Drug: Gemcitabine; Drug: Vinorelbine; Drug: Carmustine; Drug: Etoposide; Drug: Cyclophosphamide; Procedure: Autologous HCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity

    Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events.

    Measured: 6 months

Secondary outcomes (4)

  1. Pulmonary Toxicity (BCNU Pneumonitis)

    Pulmonary toxicity as assessed by the number of participants that experience BCNU pneumonitis, ie, pneumonitis due to carmustine (BCNU).

    Measured: 2 years

  2. Overall Survival (OS)

    Reports the percentage of participants surviving 6 months after PBSC infusion (transplant).

    Measured: 2 years

  3. Relapse Post-transplant

    Reports the percentage of participants that experienced relapse post-transplant.

    Measured: 2 years

  4. Survival Measures

    Reports the survival measures:

    • Freedom from progression (FFP)
    • Event-free survival (EFS)
    • Overall survival (OS)

    EFS and OS were estimated by Kaplan-Meier method

    Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2006 (estimated)
  2. Study startSep 2001
  3. Primary completionMar 2008
  4. Study completionSep 2010

Resources

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
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00388349
Sponsor's protocol ID
IRB-13511
Other IDs
1K23AI052413-01A1, BMT135
Status last verified
May 2017
First submitted
12 Oct 2006
Last updated
14 Jun 2017
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arai S, Letsinger R, Wong RM, Johnston LJ, Laport GG, Lowsky R, Miklos DB, Shizuru JA, Weng WK, Lavori PW, Blume KG, Negrin RS, Horning SJ. Phase I/II trial of GN-BVC, a gemcitabine and vinorelbine-containing conditioning regimen for autologous hematopoietic cell transplantation in recurrent and refractory hodgkin lymphoma. Biol Blood Marrow Transplant. 2010 Aug;16(8):1145-54. doi: 10.1016/j.bbmt.2010.02.022. Epub 2010 Mar 1.

    PubMed 20197102

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, Vinorelbine and Carmustine in people with Hodgkin Disease and Hodgkin's Lymphoma, run by Stanford University 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 19 inclusion and 15 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 14 Jun 2017. 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?

Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00388349, which also lists 1 linked publication.

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 14 Jun 2017.

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