Breast NeoplasmsPhase 2NCT00001805
A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab
A Phase 2 study testing Rituximab in people with Breast Neoplasms and Colonic Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This is a phase II clinical and pharmacokinetic study of suppression of human antimouse (HAMA) and antitoxin antibodies (HATA) to immunotoxin LMB-1 by Rituximab (anti-CD20). The primary objective of this study is to determine the effect of Rituximab on HAMA and HATA response to LMB-1 administered to patients with… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Neoplasms, Colonic Neoplasms, Lung Neoplasms
- What is being tested?
- Rituximab
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1999to Jun 2000
- 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
Patients must have advanced stage solid tumor with histologically or cytologically proven evaluable or measurable disease and who are refractory to standard treatment for their malignancy or for whom no effective standard therapy exists.
Must have the presence of B3 antigen on the surface of greater than 30% of the tumor cells.
Must be greater than or equal to 18 years old and be able to give informed consent.
Must have an ECOG performance status of 0 or 1 and a minimum life expectancy of 3 months.
Must have normal renal function (Creatinine less than or equal to 1.4 mg/dl), SGOT and SGPT less than or equal to 2.5 x of the upper limits of normal. Total bilirubin less than 1.5 mg/dL; AGC greater than or equal to 1.5 x 10(3) microliter; platelets greater than 100,000 per mm(3).
Must have recovered from the toxic effects of prior chemotherapy or radiation therapy. At least 3 weeks must have elapsed since the last dose of chemotherapy, hormonal therapy or radiation therapy. At least six weeks must have elapsed since the last dose of Mitomycin C and a nitrosourea.
Must not have serum neutralizing antibodies to LMB-1.
Must not have positive hepatitis B surface antigen, hepatitis C antibody or HIV.
Must not have a history of coronary artery disease, NY class II-IV CHF, arrhythmia requiring treatment and any contraindication to pressor therapy.
Must not have FEV1 and FVC less than or equal to 65% of the predicted value.
Must not have baseline serum albumin of less than 3.0 g/dl.
Must not have a history of CNS metastasis and/or known seizure disorders, or concurrent malignancy.
Must not have an acute bacterial infection that requires antibiotic therapy (unless infection is completely resolved).
Must not have any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
Must not be pregnant or breastfeeding. Patients of childbearing potential must agree to use an effective method of contraception.
Must not have a history of allergic reaction to penicillin.
Must not have lymphoma.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
This is a phase II clinical and pharmacokinetic study of suppression of human antimouse (HAMA) and antitoxin antibodies (HATA) to immunotoxin LMB-1 by Rituximab (anti-CD20). The primary objective of this study is to determine the effect of Rituximab on HAMA and HATA response to LMB-1 administered to patients with advanced carcinoma that express the B3 antigen. Other objectives include evaluation of the pharmacokinetics and anti-tumor effects.
Read the detailed description
This is a phase II clinical and pharmacokinetic study of suppression of human antimouse (HAMA) and antitoxin antibodies (HATA) to immunotoxin LMB-1 by Rituximab (anti-CD20). The primary objective of this study is to determine the effect of Rituximab on HAMA and HATA response to LMB-1 administered to patients with advanced carcinoma that express the B3 antigen. Other objectives include evaluation of the pharmacokinetics and anti-tumor effects.
- Conditions
- Breast Neoplasms, Colonic Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms
- Being tested
- Rituximab
- Keywords
- Breast Cancer, Colon Cancer, Gastric Cancer, Lung Cancer, Pancreatic Cancer
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startMar 1999
- Study completionJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001805
- Sponsor's protocol ID
- 990071
- Other IDs
- 99-C-0071
- Status last verified
- Mar 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Grossbard ML, Lambert JM, Goldmacher VS, Spector NL, Kinsella J, Eliseo L, Coral F, Taylor JA, Blattler WA, Epstein CL, et al. Anti-B4-blocked ricin: a phase I trial of 7-day continuous infusion in patients with B-cell neoplasms. J Clin Oncol. 1993 Apr;11(4):726-37. doi: 10.1200/JCO.1993.11.4.726.
PubMed 7683045Amlot PL, Stone MJ, Cunningham D, Fay J, Newman J, Collins R, May R, McCarthy M, Richardson J, Ghetie V, et al. A phase I study of an anti-CD22-deglycosylated ricin A chain immunotoxin in the treatment of B-cell lymphomas resistant to conventional therapy. Blood. 1993 Nov 1;82(9):2624-33.
PubMed 8219217Byers VS, Rodvien R, Grant K, Durrant LG, Hudson KH, Baldwin RW, Scannon PJ. Phase I study of monoclonal antibody-ricin A chain immunotoxin XomaZyme-791 in patients with metastatic colon cancer. Cancer Res. 1989 Nov 1;49(21):6153-60.
PubMed 2790828
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab
- ClinicalTrials.gov ID
- NCT00001805
- Acronym / sponsor ID
- 990071
- Conditions
- Breast Neoplasms, Colonic Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms
- Keywords
- Breast Cancer, Colon Cancer, Gastric Cancer, Lung Cancer, Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 1999
- Study completion
- Jun 2000
- First posted
- 10 Dec 2002 (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.
This is a phase II clinical and pharmacokinetic study of suppression of human antimouse (HAMA) and antitoxin antibodies (HATA) to immunotoxin LMB-1 by Rituximab (anti-CD20). The primary objective of this study is to determine the effect of Rituximab on HAMA and HATA response to LMB-1 administered to patients with advanced carcinoma that express the B3 antigen. Other objectives include evaluation of the pharmacokinetics and anti-tumor effects.
Detailed description
This is a phase II clinical and pharmacokinetic study of suppression of human antimouse (HAMA) and antitoxin antibodies (HATA) to immunotoxin LMB-1 by Rituximab (anti-CD20). The primary objective of this study is to determine the effect of Rituximab on HAMA and HATA response to LMB-1 administered to patients with advanced carcinoma that express the B3 antigen. Other objectives include evaluation of the pharmacokinetics and anti-tumor effects.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| Rituximab | 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 4 Mar 2008.
- Background: PubMed 7683045Grossbard ML, Lambert JM, Goldmacher VS, Spector NL, Kinsella J, Eliseo L, Coral F, Taylor JA, Blattler WA, Epstein CL, et al. Anti-B4-blocked ricin: a phase I trial of 7-day continuous infusion in patients with B-cell neoplasms. J Clin Oncol. 1993 Apr;11(4):726-37. doi: 10.1200/JCO.1993.11.4.726.
- Background: PubMed 8219217Amlot PL, Stone MJ, Cunningham D, Fay J, Newman J, Collins R, May R, McCarthy M, Richardson J, Ghetie V, et al. A phase I study of an anti-CD22-deglycosylated ricin A chain immunotoxin in the treatment of B-cell lymphomas resistant to conventional therapy. Blood. 1993 Nov 1;82(9):2624-33.
- Background: PubMed 2790828Byers VS, Rodvien R, Grant K, Durrant LG, Hudson KH, Baldwin RW, Scannon PJ. Phase I study of monoclonal antibody-ricin A chain immunotoxin XomaZyme-791 in patients with metastatic colon cancer. Cancer Res. 1989 Nov 1;49(21):6153-60.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rituximab in people with Breast Neoplasms and Colonic Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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?
On the ClinicalTrials.gov record for NCT00001805, which also lists 3 linked publications.
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 4 Mar 2008.