CancerPhase 2NCT00002673
Immunotherapy in Treating Patients Who Are Undergoing Bone Marrow or Peripheral Stem Cell Transplantation
A Phase 2 study testing infection prophylaxis and management in people with Cancer, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
RATIONALE: White blood cells from donors who have been exposed to cytomegalovirus may be able to help prevent this infection from occurring in patients who are undergoing bone marrow or peripheral stem cell transplantation. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Cancer
- What is being tested?
- infection prophylaxis and management
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1995to Feb 2002
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS: See General Eligibility Criteria
PATIENT CHARACTERISTICS: See General Eligibility Criteria
PRIOR CONCURRENT THERAPY: See Disease Characteristics --Patients Characteristics-- Age: 12 to 60 Performance status: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: A PHASE II STUDY OF CELLULAR ADOPTIVE IMMUNOTHERAPY AS PROPHYLAXIS FOR CYTOMEGALOVIRUS DISEASE AFTER ALLOGENEIC BONE MARROW TRANSPLANTATION
RATIONALE: White blood cells from donors who have been exposed to cytomegalovirus may be able to help prevent this infection from occurring in patients who are undergoing bone marrow or peripheral stem cell transplantation.
PURPOSE: Phase II trial to study the effectiveness of donated white blood cells to prevent cytomegalovirus infection in patients who are undergoing bone marrow or peripheral stem cell transplantation.
Read the detailed description
OBJECTIVES: I. Determine whether adoptive immunotherapy comprising donor-derived CD8+, CMV-specific, major histocompatibility complex class I-restricted cytotoxic T-lymphocyte (CTL) clones (CD8+ CMV-specific CTL clones) and CD4+ CMV-specific T-helper (Th)-cell clones is effective in preventing CMV viremia and disease in CMV-positive patients with malignancies requiring allogeneic bone marrow or peripheral blood stem cell transplantation. II. Determine whether the transfer of CD4+ CMV-specific Th-cell clones to patients with deficient responses can reconstitute CD4+ Th-cell activity and augment adoptively transferred CD8+ CMV-specific CTL clones.
OUTLINE: Allogeneic CD8+ CMV-specific, major histocompatibility complex class I-restricted cytotoxic T-lymphocyte (CTL) clones (CD8+ CMV-specific CTL clones) and CD4+ CMV-specific T-helper (Th)-cell clones are harvested and cultured in vitro at least 2 weeks before bone marrow or peripheral blood stem cell (PBSC) transplantation. Bone marrow or PBSC are infused on day 0. Patients receive the first infusion of CD8+ CMV-specific CTL clones beginning between days 28 and 45 posttransplantation, followed 8 days later by the second infusion, followed 2 days later by the first infusion of CD4+ CMV-specific Th-cell clones. Patients who receive prednisone posttransplantation or have deficient CD8+ CTL responses (i.e., less than 50% of the response measured in the immunocompetent bone marrow donor) after the second infusion of CD8+ CMV-specific CTL clones receive a third infusion of CD8+ CMV-specific CTL clones and a second infusion of CD4+ CMV-specific Th-cell clones before day 67.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12-18 months.
- Conditions
- Cancer
- Being tested
- infection prophylaxis and management
- Keywords
- stage IV breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, recurrent childhood acute lymphoblastic leukemia, recurrent adult Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent childhood rhabdomyosarcoma, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, disseminated neuroblastoma, recurrent neuroblastoma, recurrent Wilms tumor and other childhood kidney tumors, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, recurrent childhood lymphoblastic lymphoma, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia
- Medical subject headings
- Neoplasms, Breast Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Hodgkin Disease, Lymphoma, T-Cell, Cutaneous, Carcinoma, Ovarian Epithelial, Neuroblastoma, Wilms Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infection prophylaxis and managementProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2004 (estimated)
- Study startJun 1995
- Study completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Supportive care
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Stan Riddell, MD, Study chair, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002673
- Sponsor's protocol ID
- 1011.01
- Other IDs
- FHCRC-1011.01, NCI-V95-0702, CDR0000064307
- Status last verified
- Jun 2010
- First submitted
- 1 Nov 1999
- Last updated
- 17 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE II STUDY OF CELLULAR ADOPTIVE IMMUNOTHERAPY AS PROPHYLAXIS FOR CYTOMEGALOVIRUS DISEASE AFTER ALLOGENEIC BONE MARROW TRANSPLANTATION
- ClinicalTrials.gov ID
- NCT00002673
- Acronym / sponsor ID
- 1011.01
- Conditions
- Cancer
- Keywords
- stage IV breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, recurrent childhood acute lymphoblastic leukemia, recurrent adult Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent childhood rhabdomyosarcoma, stage II ovarian epithelial cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- Jun 1995
- Study completion
- Feb 2002 (actual)
- First posted
- 21 May 2004 (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.
RATIONALE: White blood cells from donors who have been exposed to cytomegalovirus may be able to help prevent this infection from occurring in patients who are undergoing bone marrow or peripheral stem cell transplantation.
PURPOSE: Phase II trial to study the effectiveness of donated white blood cells to prevent cytomegalovirus infection in patients who are undergoing bone marrow or peripheral stem cell transplantation.
Detailed description
OBJECTIVES: I. Determine whether adoptive immunotherapy comprising donor-derived CD8+, CMV-specific, major histocompatibility complex class I-restricted cytotoxic T-lymphocyte (CTL) clones (CD8+ CMV-specific CTL clones) and CD4+ CMV-specific T-helper (Th)-cell clones is effective in preventing CMV viremia and disease in CMV-positive patients with malignancies requiring allogeneic bone marrow or peripheral blood stem cell transplantation. II. Determine whether the transfer of CD4+ CMV-specific Th-cell clones to patients with deficient responses can reconstitute CD4+ Th-cell activity and augment adoptively transferred CD8+ CMV-specific CTL clones.
OUTLINE: Allogeneic CD8+ CMV-specific, major histocompatibility complex class I-restricted cytotoxic T-lymphocyte (CTL) clones (CD8+ CMV-specific CTL clones) and CD4+ CMV-specific T-helper (Th)-cell clones are harvested and cultured in vitro at least 2 weeks before bone marrow or peripheral blood stem cell (PBSC) transplantation. Bone marrow or PBSC are infused on day 0. Patients receive the first infusion of CD8+ CMV-specific CTL clones beginning between days 28 and 45 posttransplantation, followed 8 days later by the second infusion, followed 2 days later by the first infusion of CD4+ CMV-specific Th-cell clones. Patients who receive prednisone posttransplantation or have deficient CD8+ CTL responses (i.e., less than 50% of the response measured in the immunocompetent bone marrow donor) after the second infusion of CD8+ CMV-specific CTL clones receive a third infusion of CD8+ CMV-specific CTL clones and a second infusion of CD4+ CMV-specific Th-cell clones before day 67.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12-18 months.
Study design
- Primary purpose
- Supportive care
Who may qualify
- Ages
- 12 to 60 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 |
|---|---|---|
| infection prophylaxis and management | Procedure or surgery | – |
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 17 Jun 2010.
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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.
Stan Riddell, MD study chair
Fred Hutchinson Cancer Center
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 infection prophylaxis and management in people with Cancer, run by Fred Hutchinson 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?
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 17 Jun 2010. 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.
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 17 Jun 2010.