CancerPhase 1NCT00004178
Gene Therapy in Treating Patients With Cancer
A Phase 1 study testing therapeutic autologous lymphocytes in people with Cancer, run by Roger Williams Medical Center at 1 site in United States.
Trial summary
RATIONALE: Inserting a gene that has been created in the laboratory into a person's white blood cells may make the body build an immune response to kill cancer cells. PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have cancer that has not responded to previous therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- therapeutic autologous lymphocytes
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 1998to Dec 2001
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven CEA expressing adenocarcinoma
- Serum CEA levels greater than 10 ng/mL
- Failed standard therapy
- Measurable disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- 0-2
Life expectancy:
- Greater than 2 months
Hematopoietic:
- Not specified
Hepatic:
- No significant hepatic disease
- Bilirubin no greater than 3 mg/dL
- No active clinical disease caused by hepatitis B
Renal:
- No significant renal disease
- Creatinine no greater than 3 mg/dL
Cardiovascular:
- No significant cardiovascular disease
Pulmonary:
- No significant pulmonary disease
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No significant endocrine, rheumatologic, or allergic disease
- No active clinical disease caused by cytomegalovirus or tuberculosis
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma
RATIONALE: Inserting a gene that has been created in the laboratory into a person's white blood cells may make the body build an immune response to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have cancer that has not responded to previous therapy.
Read the detailed description
OBJECTIVES:
- Determine the safety and maximum tolerated dose of T cells activated in vitro and modified with chimeric anti-CEA immunoglobulin T cell receptors (Ig TCR) in patients with CEA expressing adenocarcinoma.
- Determine the pharmacokinetics of this regimen by the persistence of modified T cells in the blood of these patients.
- Evaluate the immunogenicity of murine sequences in chimeric anti-CEA Ig TCR.
- Assess immunologic parameters which correlate with the efficacy of this regimen in these patients.
- Evaluate, in a preliminary manner, the efficacy of this regimen in patients with CEA bearing tumors.
OUTLINE: This is a dose escalation study.
Peripheral blood lymphocytes (PBL) are harvested. PBL are activated in vitro and then modified with recombinant chimeric anti-CEA immunoglobulin T cell receptors (Ig TCR). Ig TCR modified T cells are reinfused over 30-60 minutes.
The estimated maximum tolerated dose (MTD) is defined as the dose at which 2 of 6 patients experience unacceptable toxicity. If the MTD is not reached within the first cohort, a second cohort of 3 patients then receives 4 doses of modified T cells at a higher dose.
Patients are followed every 2 weeks for 2 months.
PROJECTED ACCRUAL: A total of 6-9 patients will be accrued for this study.
- Conditions
- Cancer
- Being tested
- therapeutic autologous lymphocytes
- Keywords
- stage III colon cancer, stage IV colon cancer, stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer, recurrent non-small cell lung cancer, stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, recurrent esophageal cancer, stage III cervical cancer, recurrent cervical cancer, stage IVB cervical cancer
- Medical subject headings
- Neoplasms, Colonic Neoplasms, Stomach Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Rectal Neoplasms, Esophageal Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic autologous lymphocytesBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2004 (estimated)
- Study startApr 1998
- Primary completionDec 2000
- Study completionDec 2001
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.
- 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 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Roger Williams Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Investigators
- Richard P. Junghans, MD, PhD, Study chair, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004178
- Sponsor's protocol ID
- CDR0000067388
- Other IDs
- BIDMC-941101148, NEDH-941101148, NCI-V99-1577
- Status last verified
- May 2006
- First submitted
- 21 Jan 2000
- Last updated
- 10 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00004178
- Acronym / sponsor ID
- CDR0000067388
- Conditions
- Cancer
- Keywords
- stage III colon cancer, stage IV colon cancer, stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer, recurrent non-small cell lung cancer, stage II pancreatic cancer, stage III pancreatic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Roger Williams Medical CenterUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Study start
- Apr 1998
- Primary completion
- Dec 2000 (actual)
- Study completion
- Dec 2001 (actual)
- First posted
- 19 Apr 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: Inserting a gene that has been created in the laboratory into a person's white blood cells may make the body build an immune response to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have cancer that has not responded to previous therapy.
Detailed description
OBJECTIVES:
- Determine the safety and maximum tolerated dose of T cells activated in vitro and modified with chimeric anti-CEA immunoglobulin T cell receptors (Ig TCR) in patients with CEA expressing adenocarcinoma.
- Determine the pharmacokinetics of this regimen by the persistence of modified T cells in the blood of these patients.
- Evaluate the immunogenicity of murine sequences in chimeric anti-CEA Ig TCR.
- Assess immunologic parameters which correlate with the efficacy of this regimen in these patients.
- Evaluate, in a preliminary manner, the efficacy of this regimen in patients with CEA bearing tumors.
OUTLINE: This is a dose escalation study.
Peripheral blood lymphocytes (PBL) are harvested. PBL are activated in vitro and then modified with recombinant chimeric anti-CEA immunoglobulin T cell receptors (Ig TCR). Ig TCR modified T cells are reinfused over 30-60 minutes.
The estimated maximum tolerated dose (MTD) is defined as the dose at which 2 of 6 patients experience unacceptable toxicity. If the MTD is not reached within the first cohort, a second cohort of 3 patients then receives 4 doses of modified T cells at a higher dose.
Patients are followed every 2 weeks for 2 months.
PROJECTED ACCRUAL: A total of 6-9 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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 |
|---|---|---|
| therapeutic autologous lymphocytes | Biological | – |
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 10 Jun 2011.
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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.
Richard P. Junghans, MD, PhD study chair
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing therapeutic autologous lymphocytes in people with Cancer, run by Roger Williams Medical 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 10 Jun 2011. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 10 Jun 2011.