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MelanomaPhase 1NCT02203864

Dose Escalation Study to Evaluate Safety and Tolerability of an Allogeneic Tumor Vaccine BIWB 2 in Patients With Advanced Malignant Melanoma

A Phase 1 study testing BIBW2 component A and BIBW2 component B in people with Melanoma, run by Boehringer Ingelheim.

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

Evaluation of safety and tolerability of four intradermal injections given at two week intervals. In addition the efficacy of transferrinfection was determined by quantifying Interleukin 2 (IL-2), which was locally produced by the implanted, transfected allogenic melanoma cells at the injection sites. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
BIBW2 component A and BIBW2 component B
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
No sites listed yet
Study dates
Aug 1998to Feb 2001
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

Who may be able to join

  • Patients who fail to respond to conventional therapy or for whom conventional therapy is not available
  • Metastatic melanoma (stage IV AJCC) which is surgically or medically incurable because of distant metastatic disease (i.e., a metastasis not in the same lymph node draining area as the primary malignant melanoma). Histologic confirmation of stage IV is required. Measurable disease that can be routinely assessed by physical examination and/or non-invasive radiological procedures
  • Karnofsky performance status is at least 60% and life expectancy greater than 4 months
  • Male or female, minimum age 18 years
  • Written informed consent of the patient in accordance with good clinical practice and local legislation
  • Availability of material for autologous Delayed Type Hypersensitivity (DTH) testing (material derived from autologous melanoma metastases and in-house preparation successful) is a requisite for entering the study
  • Patients have to undergo biopsy of at least one metastasis before the first and after the last vaccination

Who cannot join

  • Patient who have received any chemotherapy, corticosteroids, radiotherapy (stereotactic irradiation permitted), immunotherapy (e.g. Granulocyte Macrophage Colony Stimulating Factor, Granulocyte Colony Stimulating Factor) or any other investigational drugs in the 4 weeks prior to the first vaccination or prior to surgical removal of tumor specimens for DTH material preparation (patients are not permitted to receive such therapies 4 weeks prior to first cell inoculation except of tumor reductive surgery which are medically indicated)
  • Patients with active intracranial metastases (CT/MRI) or choroidal melanoma
  • Patients with active autoimmune disease
  • Patients with organ allografts
  • Patients with evidence of one or more of the following infections: HIV-1, HIV-2, Hepatitis B Virus, Hepatitis C Virus, Human T lymphotropic Virus-1
  • Patients with active systemic infections or other major medical illness of the cardiovascular organ system [e.g. coronary heart disease (New York Heart Association class III or IV), history of clinically significant ventricular arrhythmias or angina], coagulation disorder, respiratory or nervous system disorder or with severe endocrinological disease
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  • Women of childbearing potential with a positive pregnancy test or without appropriate contraception (e.g. IUD [ Intra-Uterine Device], oral contraceptives) until at least 28 days after the last vaccination
  • Lactating women
  • Impaired renal or hepatic function (serum creatinine > 1.5 mg/dl or creatinine clearance < 75 ml/min). In amendments 1 and 3 serum creatinine levels were changed to 2.5 mg/dl and creatinine clearance was reduced to 30 ml/min
  • Impaired hematologic function with:
  • White Blood Count (WBC) < 2500/mm**3 or
  • absolute lymphocyte count < 1500/mm**3 or
  • hemoglobin < 8 g/dl or
  • platelets < 100,000/mm**3
  • Evidence for the existence or history of other malignant neoplasms (except adequately treated basal cell carcinoma and carcinoma in situ of the cervix)

About this study

Official title: An Open-label, Multicenter, Controlled, Combined Parallel Group and Dose Escalation (0, 0.12, 1.2, 12.0 µg IL-2/10**8 Cells/24 Hours) Study, to Evaluate the Safety and Tolerability of an Allogeneic Tumor Vaccine BIWB 2 Containing Melanoma Cells Transfected With the Human IL-2 Gene in Patients With Advanced Malignant Melanoma

Evaluation of safety and tolerability of four intradermal injections given at two week intervals. In addition the efficacy of transferrinfection was determined by quantifying Interleukin 2 (IL-2), which was locally produced by the implanted, transfected allogenic melanoma cells at the injection sites. Further determination of tumor specific and clinical host responses induced or augmented by the treatment were determined.

Conditions
Melanoma
Being tested
BIBW2 component A, BIBW2 component B
Medical subject headings
Melanoma

What participants receive

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

  • BIBW2 component ABiological

    BIBW2 without IL-2 secreting cell line

  • BIBW2 component BBiological

    BIBW2 with IL-2 secreting cell line

Study groups in NCT02203864
Study groupRoleWhat they receive
BIBW2 with IL-2 secreting cell lineExperimentalNot described
Receives: Biological: BIBW2 component B
BIBW2 without IL-2 secreting cell lineExperimentalNot described
Receives: Biological: BIBW2 component A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of dose limiting toxicity (DLT)

    Measured: up to 6 weeks

  2. Number of patients with adverse events

    Measured: up to 28 days after the last vaccination

Secondary outcomes (10)

  1. Grading of local reactions on a 4-point-scale

    Measured: up to 28 days after the last vaccination

  2. Number of patients with IL-2 transcripts in biopsies of injection sites

    Measured: 4-6 and 48 hours after first vaccination

  3. Number of patients with delayed type hypersensitivity skin reaction

    delayed type hypersensitivity testing

    Measured: up to 28 days after the last vaccination

  4. Number of antigen-positive cells in biopsies from metastatic lesions

    Measured: up to 28 days after the last vaccination

  5. Number of antigen-positive cells in the cellular infiltrate at the vaccination site

    Measured: up to 28 days after the last vaccination

  6. Number of patients with a positive reaction to Multitest Merieux

    positive reaction: sum of all indurations of all existing reactions => 10 mm (male) or >= 5 mm (female)

    Measured: up to day 14

  7. Change in T cell proliferation as ratio of post-vaccination to pre-vaccination

    Measured: up to 28 days after the last vaccination

  8. Change in S-100 beta protein level in serum

    Measured: up to 28 days after the last vaccination

  9. Number of patients with clinical response

    clinical response = complete and partial response

    Measured: up to 28 days after the last vaccination

  10. Change in interferon-gamma secretion as ratio of post-vaccination to pre-vaccination

    Measured: up to 28 days after the last vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2014 (estimated)
  2. Study startAug 1998
  3. Primary completionFeb 2001

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
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02203864
Sponsor's protocol ID
1155.2
Status last verified
Jul 2014
First submitted
29 Jul 2014
Last updated
31 Jul 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIBW2 component A and BIBW2 component B in people with Melanoma, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. 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: finished, as of the sponsor's last update on 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

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.

What does the primary outcome measure?

Occurrence of dose limiting toxicity (DLT) (time frame: up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02203864.

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 31 Jul 2014.

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