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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in United States

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.

  1. First posted27 Jan 2003 (estimated)
  2. Study startAug 2000

Resources

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
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

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.

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