Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma

Inclusion Criteria:

• Histologic diagnosis of osteosarcoma.

• Patients with at least one episode of relapse in the lung (without limitation ofnumber of episodes), following surgical resection of all gross metastatic disease.

• Surgical resection of all possible sites of suspected pulmonary metastases in orderto achieve a complete remission within 8 weeks prior to study enrollment. Note: Ifsurgery related changes such as atelectasis are seen on the post-operative CT scan,patients will remain eligible to enroll as long as the operating surgeon believesthat all sites of metastases were resected. Patients with positive microscopicmargins will be eligible to enroll.

• Pathological confirmation of metastases from at least one of the resected sites.

• Age ≥ 8 years of age and <30 years of age.

• Patients must be able to receive subcutaneous injections.

• Performance level as measured by Karnofsky ≥60% for patients > 16 years of age orLansky ≥ 60% for patients ≤ 16 years of age.

• Female patients of childbearing potential must have a negative serum blood pregnancytest during screening and a negative urine pregnancy test within 3 days prior toreceiving the first dose of study drug. If the screening serum test is done within 3days prior to receiving the first dose of study drug, a urine test is not required.If a patient is of childbearing potential the patient must agree to use effectivecontraception during the study and for 120 days after the last dose of study drug.

• If male, agrees to use an adequate method of contraception starting with the firstdose of study drug through 120 days after the last dose of study drug

• Life expectancy of > two months

• Experienced resolution of toxic effect(s) of the most recent prior anti-cancertherapy to Grade <1 (except alopecia, cytopenia, or neuropathy). If a patientunderwent major surgery or radiation therapy of >30 Gy, they must have recoveredfrom the toxicity and/or complications from the intervention.

• Patients must meet the following laboratory criteria

1. Adequate hepatic function with serum aspartate aminotransferase (AST) andalanine aminotransferase (ALT) ≤ 5 times the upper limit of normal (ULN) andtotal serum bilirubin < 2.5 times the ULN or Direct bilirubin ≤ ULN forpatients with total bilirubin levels > 2.5 X ULN

2. Absolute neutrophil count ≥ 500/dL

3. Platelet count ≥ 20,000/L

4. Creatinine ≤ 1.5 X the ULN or measurement of calculated creatinine clearance (CrCl) ≥ 60 ml/minute

Exclusion Criteria:

• History or current evidence of any condition, therapy, or laboratory abnormalitythat might confound the results of the study, interfere with the patient'sparticipation for the full duration of the study, or is not in the best interest ofthe patient to participate, in the opinion of the treating Investigator, including,but not limited to:

• Another known malignancy other than osteosarcoma that is progressing orrequires active treatment.

• Any prior history of other cancer within the prior 5 years with the exceptionof adequately treated basal cell carcinoma or cervical intraepithelialneoplasia [CIN]/cervical carcinoma in situ or melanoma in situ).

• Active infection requiring systemic therapy.

• Known active central nervous system (CNS) metastases and/or carcinomatousmeningitis.

• New recurrence of osteosarcoma metastasis in any location other than lung

• Known psychiatric or substance abuse disorders that would interfere with cooperationwith the requirements of the study.

• Currently participating and receiving study therapy or has participated in a studyof an investigational agent and received study therapy or used an investigationaldevice within 4 weeks of the first dose of study drug.

• Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).

• Known active hepatitis B (e.g., hepatitis B surface antigen-reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid [qualitative]). Patients with pasthepatitis B virus (HBV) infection or resolved HBV infection (defined as the presenceof hepatitis B core antibody [HBc Ab] and absence of HBsAg) are eligible. HBV DNAtest must be performed in these patients prior to study treatment. Patients positivefor hepatitis C virus (HCV) antibody are eligible only if polymerase chain reactionis negative for HCV RNA.

• Known history of chronic granulomatous diseases, florid autoimmune diseases,diseases treated with immunosuppressive drugs, hyperthyroidism with tachycardia,tuberculosis, parasitosis or Crohn's disease.

• If female, is pregnant or breastfeeding.

• Patients must have had no systemic chemotherapy or immunotherapy in the three weeksprior to enrollment and must have fully recovered from side effects of priortreatment at enrollment.

• Patients may not receive any additional chemotherapeutic agent (either conventionalor experimental) while on study.

• Patients must not have received radiation therapy for up to two weeks prior toenrollment.

• Patients must have no known prior allergy to Iscador® P or any other Viscum albumproducts.

• Patients must not receive concomitant treatment with immunostimulant orimmunosuppressive drugs.