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NeuroblastomaPhase 1NCT00003023

Monoclonal Antibody A1G4 Plus BCG in Treating Patients With Cancer

A Phase 1 study testing BCG vaccine and monoclonal antibody A1G4 anti-idiotype vaccine in people with Neuroblastoma and Sarcoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Combining monoclonal antibody A1G4 with BCG may kill more tumor cells. Read more about this study

Who is it for?
Any age
Conditions the study is for
Neuroblastoma, Sarcoma
What is being tested?
BCG vaccine and monoclonal antibody A1G4 anti-idiotype vaccine
Type of treatment
Vaccines
How many people
24 participants
Where
1 siteUnited States
Study dates
Mar 1997to Jan 2005
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed GD2 positive tumors which include:
  • High risk neuroblastoma (stage IV, or N-myc amplified, or localized neuroblastoma multiply recurrent)
  • Recurrent or metastatic osteosarcoma
  • Recurrent or metastatic GD2 positive sarcomas
  • If free of disease, patient must be fully recovered from toxic effects or complications of prior treatments (chemotherapy or surgery)
  • No greater than 6 months since last chemotherapy or surgery before first injection of A1G4

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • Not specified

Life expectancy:

  • At least 6 months

Hematopoietic:

  • Absolute neutrophil count greater than 500/mm^3
  • Absolute leukocyte count greater than 500/mm^3
  • Peripheral T-cell phytohemagglutinin activation (PHA) at least 50% of normal

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No significant heart disease (NYHA class III or IV)

Other:

  • No other serious intercurrent illnesses
  • No active infections requiring antibiotics
  • No active bleeding
  • No primary immunodeficiency
  • Not pregnant or nursing
  • Adequate contraception required of all fertile patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent antibiotics
  • No prior mouse antibodies and detectable human antimouse antibody (HAMA) titer

Chemotherapy:

  • See Disease Characteristics
  • At least 6 weeks since nitrosoureas
  • At least 4 weeks since other systemic chemotherapy

Endocrine therapy:

  • No concurrent nonsteroidal anti-inflammatory agents
  • No concurrent corticosteroid

Radiotherapy:

  • At least 4 weeks since radiotherapy
  • No prior radiation therapy to the spleen

Surgery:

  • See Disease Characteristics
  • No splenectomy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

Official title: Phase I Trial of A1G4 Anti-Idiotypic Monoclonal Antibody With Bacille-Calmette-Guerin (BCG) Adjuvant in High Risk Patients With GD2 Positive Tumors

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody A1G4 with BCG may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody A1G4 plus BCG in treating patients with cancer.

Read the detailed description

OBJECTIVES:

  • Assess the toxicity and feasibility of immunizing patients with anti-idiotypic rat monoclonal antibody A1G4 combined with Bacillus Calmette Guerin (BCG) adjuvant.
  • Determine whether immunization with A1G4 combined with BCG results in an immune response directed against GD2 ganglioside in patients.

OUTLINE: All patients are treated with A1G4 diluted in sterile physiologic saline mixed with Bacillus Calmette Guerin (BCG) organisms. The vaccine is injected intradermally in multiple sites. Booster immunizations are administered during weeks 2, 4, 8, 12, 20, 28, 36, 44, 52. Immunizations are not administered in limbs where draining lymph nodes have been surgically removed or previously irradiated. Isoniazid is administered for 5 days after each BCG injection. If severe skin reactions are present at the injection site, the BCG dose is decreased. If skin reactions persist, the BCG dose is stopped but A1G4 injections continue.

At least 6 patients are accrued at each dose level of A1G4. Dose escalation is not carried out until patients have been followed for at least 8 weeks after the first immunization without encountering grade 3 or worse non-skin toxicity.

If 0-1 patient experiences dose limiting toxicity (DLT) at a given dose level, then patients are accrued to the next higher dose level. If 2 or more patients experience DLT, the MTD is defined as the previous dose level.

Patients are followed for at least 1 year.

PROJECTED ACCRUAL: A total of 24 patients are expected to complete this study. If patients are removed early from the study prior to evaluation for serological response, additional patients will be accrued until 6 patients are evaluable for serological response.

Being tested
BCG vaccine, monoclonal antibody A1G4 anti-idiotype vaccine
Keywords
metastatic osteosarcoma, recurrent adult soft tissue sarcoma, disseminated neuroblastoma, stage 4S neuroblastoma, recurrent neuroblastoma, recurrent osteosarcoma, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, stage IV adult soft tissue sarcoma
Medical subject headings
Neuroblastoma, Sarcoma, Osteosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCG vaccineBiological

  • monoclonal antibody A1G4 anti-idiotype vaccineBiological

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 startMar 1997
  3. Primary completionJan 2005

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
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003023
Sponsor's protocol ID
97-024
Other IDs
P30CA008748, MSKCC-97024, NCI-G97-1268
Status last verified
Jan 2013
First submitted
1 Nov 1999
Last updated
18 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BCG vaccine and monoclonal antibody A1G4 anti-idiotype vaccine in people with Neuroblastoma and Sarcoma, run by Memorial Sloan Kettering Cancer Center 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 18 Jan 2013. 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 NCT00003023.

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 18 Jan 2013.

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