Breast NeoplasmsPhase 1NCT00001270
Feasibility Study of Interleukin 1-Alpha With Ifosfamide, CBDCA, and Etoposide With Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma
A Phase 1 study testing interleukin-1 in people with Breast Neoplasms and Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This is a phase I/II study of interleukin-1, G-CSF and high dose ICE chemotherapy with autologous bone marrow transplant in patients with relapsed breast, testicular and lymphoid cancers. The initial goal of this study was to define the toxicity of interleukin-1 administered for 7 days prior to ICE chemotherapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Neoplasms, Lymphoma, Neoplasm Metastasis
- What is being tested?
- interleukin-1
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1991to Mar 2000
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
A history of pathologically documented (clinical documentation may be acceptable at relapse):
Breast cancer: metastatic or locally advanced (Stage III/IV) with stable minimal (less than or equal to 2 cm) residual disease after 2 cycles of appropriate combination chemotherapy may start BMT.
Non-Hodgkin's lymphomas: all stages of relapsed or induction failure (FSC, FM, FL, DSC, DL, DM, DIDL, IBL, LBL, SNC) after appropriate chemotherapy.
Hodgkin's lymphomas: all stages of chemotherapy induction failures, first relapse less than or equal to 1 year from chemotherapy induced remission, first relapse greater than 1 year from chemotherapy induced remission if there is extranodal involvement at relapse, greater than or equal to 2 relapses (one may be after radiation) following appropriate combination chemotherapy, or relapse at any time from radiation therapy with stage IIB, IIIB, IV A/B.
Testicular cancer: all stages of relapsed or induction failure following appropriate combination chemotherapy.
No evidence of central nervous system cancer.
Patients must be between 18 and 65 years old.
Normal cardiac function: no history of angina pectoris, myocardial infarction, congestive heart failure or ejection fraction less than 40 percent.
Creatinine clearance greater than or equal to 45 cc/min/m(2), bilirubin less than or equal to 1.5, SGOT less than or equal to 2x normal, and normal PT, PTT and calcium.
Negative HIV serology and hepatitis B surface antigen.
Adequate pulmonary function (PFTs are only obtained in patients with clinical evidence of pulmonary dysfunction): DLCO greater than 50 percent, compensated for Hgb, FEV 1 greater than 55 percent and PO2 greater than 60.
Negative bilateral bone marrow biopsies prior to bone marrow harvest.
No evidence of metastatic disease to the pelvis on plain film or bone scan.
Karnofsky performance status greater than or equal to 70 and a life expectancy greater than or equal to 60 days.
No evidence of pregnancy or risk of pregnancy at the time of transplantation in women.
Ability to give informed consent.
Good psychiatric and medical risk.
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 I/II study of interleukin-1, G-CSF and high dose ICE chemotherapy with autologous bone marrow transplant in patients with relapsed breast, testicular and lymphoid cancers. The initial goal of this study was to define the toxicity of interleukin-1 administered for 7 days prior to ICE chemotherapy. A total of 22 patients have been treated with IL-1 and ICE and results showed a more rapid engraftment (4.5 days) with IL-1. A second cohort of 18 patients also received G-CSF and engraftment was further shortened in some subgroups. Overall, the median time to engraftment was 16 days with both IL-1 and G-CSF. Accrual will continue to further define the toxicity and efficacy of this regimen.
Read the detailed description
This is a phase I/II study of interleukin-1, G-CSF and high dose ICE chemotherapy with autologous bone marrow transplant in patients with relapsed breast, testicular and lymphoid cancers. The initial goal of this study was to define the toxicity of interleukin-1 administered for 7 days prior to ICE chemotherapy. A total of 22 patients have been treated with IL-1 and ICE and results showed a more rapid engraftment (4.5 days) with IL-1. A second cohort of 18 patients also received G-CSF and engraftment was further shortened in some subgroups. Overall, the median time to engraftment was 16 days with both IL-1 and G-CSF. Accrual will continue to further define the toxicity and efficacy of this regimen.
- Conditions
- Breast Neoplasms, Lymphoma, Neoplasm Metastasis, Testicular Neoplasms
- Being tested
- interleukin-1
- Keywords
- Chemotherapy, High Dose, Protection
- Medical subject headings
- Breast Neoplasms, Lymphoma, Neoplasm Metastasis, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interleukin-1Drug
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 startJun 1991
- Study completionMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 1
- Primary purpose
- Treatment
- Enrolment
- 85 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001270
- Sponsor's protocol ID
- 910156
- Other IDs
- 91-C-0156
- Status last verified
- May 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Jagannath S, Dicke KA, Armitage JO, Cabanillas FF, Horwitz LJ, Vellekoop L, Zander AR, Spitzer G. High-dose cyclophosphamide, carmustine, and etoposide and autologous bone marrow transplantation for relapsed Hodgkin's disease. Ann Intern Med. 1986 Feb;104(2):163-8. doi: 10.7326/0003-4819-104-2-163.
PubMed 3511811Neta R, Oppenheim JJ. Cytokines in therapy of radiation injury. Blood. 1988 Sep;72(3):1093-5.
PubMed 2458148
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
- Feasibility Study of Interleukin 1-Alpha With Ifosfamide, CBDCA, and Etoposide With Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma
- ClinicalTrials.gov ID
- NCT00001270
- Acronym / sponsor ID
- 910156
- Conditions
- Breast Neoplasms, Lymphoma, Neoplasm Metastasis, Testicular Neoplasms
- Keywords
- Chemotherapy, High Dose, Protection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 1991
- Study completion
- Mar 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 I/II study of interleukin-1, G-CSF and high dose ICE chemotherapy with autologous bone marrow transplant in patients with relapsed breast, testicular and lymphoid cancers. The initial goal of this study was to define the toxicity of interleukin-1 administered for 7 days prior to ICE chemotherapy. A total of 22 patients have been treated with IL-1 and ICE and results showed a more rapid engraftment (4.5 days) with IL-1. A second cohort of 18 patients also received G-CSF and engraftment was further shortened in some subgroups. Overall, the median time to engraftment was 16 days with both IL-1 and G-CSF. Accrual will continue to further define the toxicity and efficacy of this regimen.
Detailed description
This is a phase I/II study of interleukin-1, G-CSF and high dose ICE chemotherapy with autologous bone marrow transplant in patients with relapsed breast, testicular and lymphoid cancers. The initial goal of this study was to define the toxicity of interleukin-1 administered for 7 days prior to ICE chemotherapy. A total of 22 patients have been treated with IL-1 and ICE and results showed a more rapid engraftment (4.5 days) with IL-1. A second cohort of 18 patients also received G-CSF and engraftment was further shortened in some subgroups. Overall, the median time to engraftment was 16 days with both IL-1 and G-CSF. Accrual will continue to further define the toxicity and efficacy of this regimen.
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 |
|---|---|---|
| interleukin-1 | 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 3511811Jagannath S, Dicke KA, Armitage JO, Cabanillas FF, Horwitz LJ, Vellekoop L, Zander AR, Spitzer G. High-dose cyclophosphamide, carmustine, and etoposide and autologous bone marrow transplantation for relapsed Hodgkin's disease. Ann Intern Med. 1986 Feb;104(2):163-8. doi: 10.7326/0003-4819-104-2-163.
- Background: PubMed 2458148Neta R, Oppenheim JJ. Cytokines in therapy of radiation injury. Blood. 1988 Sep;72(3):1093-5.
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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 1 study testing interleukin-1 in people with Breast Neoplasms and Lymphoma, 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 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?
On the ClinicalTrials.gov record for NCT00001270, which also lists 2 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.