Lung CancerPhase 1NCT00006347
Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
A Phase 1 study testing indium In 111 monoclonal antibody MN-14 and yttrium Y 90 monoclonal antibody MN-14 in people with Lung Cancer, run by Garden State Cancer Center at the Center for Molecular Medicine and Immunology at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- indium In 111 monoclonal antibody MN-14 and yttrium Y 90 monoclonal antibody MN-14
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to not given
- 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 or cytologically confirmed small cell lung cancer (SCLC)
- Must have received at least one prior course of standard chemotherapy and, if indicated, up to 6,900 cGy of thoracic radiotherapy
- Patients who received prior radiotherapy must show evidence of progressive disease
- Patients who received no prior radiotherapy to the primary tumor must show evidence of stable or progressive disease
- Measurable disease
- Must have evidence of carcinoembryonic antigen (CEA) production or expression documented by one of the following:
- Serum CEA at least 10 ng/mL
- Positive immunohistology of either the primary tumor or a metastasis with CEA specific monoclonal antibody
- Must have unilateral bone marrow biopsy with less than 25% tumor involvement
- No known, active brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- WBC at least 3,000/mm^3
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2 mg/dL
- AST no greater than 2 times upper limit of normal (ULN)
- No hepatitis B or C
- No other serious liver abnormality
Renal:
- Creatinine no greater than 1.5 times ULN
- No urinary incontinence
Cardiovascular:
- Ejection fraction at least 50%
Pulmonary:
- FEV_1 and FVC at least 60%
- DLCO at least 50% predicted
Other:
- No severe anorexia, nausea, or vomiting
- No other significant medical problems
- No prisoners
- No reactivity to humanized MN-14 (in patients with prior exposure to chimeric or humanized antibody)
- HIV negative
- No active HIV-related disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months following study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Chemotherapy
- No concurrent growth factors (e.g., filgrastim [G-CSF])
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- No prior high dose chemotherapy with stem cell transplantation
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- Prior radiotherapy to less than 30% of red marrow (including standard chest x-ray for limited stage SCLC) allowed
Surgery:
- At least 4 weeks since prior major surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Garden State Cancer Center
Belleville, New Jersey, 07109
About this study
Official title: Phase I Non-Myeloablative Trial With 90Y-Humanized MN-14 (Anti-CEA) Antibody for Relapsed or Refractory Small Cell Lung Cancer (SCLC)
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory small cell lung cancer.
Read the detailed description
OBJECTIVES:
- Determine the dose limiting toxicity and maximum tolerated dose of yttrium Y 90 anti-CEA monoclonal antibody MN-14 in patients with relapsed or refractory small cell lung cancer.
- Determine the dosimetric and pharmacokinetic properties of this treatment regimen in the blood, normal organs, and tumors of these patients.
- Determine the stability and complexation with circulating carcinoembryonic antigen of this radioantibody in the plasma of these patients.
- Determine the antibody response of these patients treated with this regimen.
- Determine the antitumor effects of this treatment regimen in these patients.
OUTLINE: This is a dose escalation study of yttrium Y 90 anti-CEA monoclonal antibody MN-14 (90Y-hMN-14). Patients are stratified according to prior radiotherapy (yes vs no).
Patients undergo pretherapy imaging with indium In 111 anti-CEA monoclonal antibody MN-14 IV over 30-40 minutes on day -7 or -6 followed by external scintigraphy on days -7 or -6 to 0.
Patients who show positive localization of at least one documented tumor site receive 90Y-hMN-14 IV over 30-40 minutes on day 0.
Cohorts of 3-6 patients receive escalating doses of 90Y-hMN-14 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
Patients are followed at 2, 4, 8, and 12 weeks; every 3 months for 2 years; and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 10-14 months.
- Conditions
- Lung Cancer
- Being tested
- indium In 111 monoclonal antibody MN-14, yttrium Y 90 monoclonal antibody MN-14
- Keywords
- recurrent small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indium In 111 monoclonal antibody MN-14Radiation
yttrium Y 90 monoclonal antibody MN-14Radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- Garden State Cancer Center at the Center for Molecular Medicine and Immunology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Jack D. Burton, MD, Study chair, Garden State Cancer Center at the Center for Molecular Medicine and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006347
- Sponsor's protocol ID
- CDR0000068199
- Other IDs
- CMMI-C-057A-99, NCI-H00-0064
- Status last verified
- Apr 2003
- First submitted
- 4 Oct 2000
- Last updated
- 3 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Non-Myeloablative Trial With 90Y-Humanized MN-14 (Anti-CEA) Antibody for Relapsed or Refractory Small Cell Lung Cancer (SCLC)
- ClinicalTrials.gov ID
- NCT00006347
- Acronym / sponsor ID
- CDR0000068199
- Conditions
- Lung Cancer
- Keywords
- recurrent small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Garden State Cancer Center at the Center for Molecular Medicine and ImmunologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2000
- First posted
- 27 Jan 2003 (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: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory small cell lung cancer.
Detailed description
OBJECTIVES:
- Determine the dose limiting toxicity and maximum tolerated dose of yttrium Y 90 anti-CEA monoclonal antibody MN-14 in patients with relapsed or refractory small cell lung cancer.
- Determine the dosimetric and pharmacokinetic properties of this treatment regimen in the blood, normal organs, and tumors of these patients.
- Determine the stability and complexation with circulating carcinoembryonic antigen of this radioantibody in the plasma of these patients.
- Determine the antibody response of these patients treated with this regimen.
- Determine the antitumor effects of this treatment regimen in these patients.
OUTLINE: This is a dose escalation study of yttrium Y 90 anti-CEA monoclonal antibody MN-14 (90Y-hMN-14). Patients are stratified according to prior radiotherapy (yes vs no).
Patients undergo pretherapy imaging with indium In 111 anti-CEA monoclonal antibody MN-14 IV over 30-40 minutes on day -7 or -6 followed by external scintigraphy on days -7 or -6 to 0.
Patients who show positive localization of at least one documented tumor site receive 90Y-hMN-14 IV over 30-40 minutes on day 0.
Cohorts of 3-6 patients receive escalating doses of 90Y-hMN-14 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
Patients are followed at 2, 4, 8, and 12 weeks; every 3 months for 2 years; and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 10-14 months.
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 |
|---|---|---|
| indium In 111 monoclonal antibody MN-14 | Radiation | – |
| yttrium Y 90 monoclonal antibody MN-14 | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2009.
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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.
Jack D. Burton, MD study chair
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
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 indium In 111 monoclonal antibody MN-14 and yttrium Y 90 monoclonal antibody MN-14 in people with Lung Cancer, run by Garden State Cancer Center at the Center for Molecular Medicine and Immunology 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: status not confirmed, as of the sponsor's last update on 3 Mar 2009. 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?
Results are not available in the source record.
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 3 Mar 2009.